ZONE Medical MEDCAPTAIN NAVI-30 User manual

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

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.
MEDCAPTAIN and its Chinese name, and
are registered trademarks owned by MEDCAPTAIN.
Statement
MEDCAPTAIN reserves the final interpretation right to this Manual.
To provide accurate and efficient product services, MEDCAPTAIN
shall have the right to change the contents of this Manual without
prior notice under the premise of complying with medical device
regulations. The latest version accumulates all changes made in
earlier versions.
MEDCAPTAIN is responsible for the safety, reliability and
performance of this product, only if:
The product is used in accordance with this Manual.
All installations, replacements, tests, modifications and repairs
are conducted by technicians authorized to do so by
MEDCAPTAIN.
All replacement components and accessories are provided by
MEDCAPTAIN.
All maintenance service records are kept.

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
Version of operation manual: First release
Software release version: V1
Issued on: August 2018
V1.1
Updated some parameters of the built-in battery.
Issued on: April 2019

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. However, a product damage or fault is not covered
by the warranty if it is caused by:
Operator error;
Improper use;
Out-of-range grid voltage;
Force majeure such as natural disasters;
Replacement with or use of any component, accessory or
consumable other than authorized by MEDCAPTAIN; or
Other damages/faults not caused by the product.
After the warranty period expires, MEDCAPTAIN shall
continue to provide paid maintenance service within the service
life of the product.
Feel free to contact us or your local distributor if you have any
problem in using the product.
Contact our after-sales service department:

Contents
1 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.................................................................35

Overview
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1Overview
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
using infrared light and then indicates the vein positions on the skin
surface above the veins by using light during operation. By
observing the vascular system projected on the skin surface,
qualified medical personnel can find a vein of appropriate size and
position for venipuncture.
Veins beneath skin are detected by using the near-infrared light
and then projected on the body surface by using the
high-definition vein illuminator, implementing real-time and
accurate display of vein positions.
This device can be placed at any place above the detection area
to project the vein positions accurately. It does not need to be
fastened at a specific position above the detection area for
accurate projection.
Easy to operate. Users can press to power on/off the device.
Lightweight structural design, easy to take along.

Overview
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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.
The size of the projection window can be adjusted to adapt to
different patients and different detection positions.
This device can be used to detect and display the depth of the
vein beneath skin.
The NAVI-60 vein illuminator is equipped with a display screen
to display various operation information like the remaining
battery capacity, mode, color, and projection size.
A lithium battery is built in to allow long-time portable use.
This device can be used while it is connected to an external
power supply for battery charging.
This device can be used together with a support or trolley.
1.4 Model Differences
Product Model
Difference
NAVI-30
Without a display screen
NAVI-60
With a display screen

Safety
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2Safety
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. Failure to
follow them may affect the normal use of the product.
Please read all warnings and cautions contained herein
carefully.
WARNING:
The vein illuminator must be operated by professional medical
personnel or under the guidance of clinicians. In addition, the
operator must receive a training related to the use of this device.
High-frequency surgical equipment, mobile phones, wireless
devices, and defibrillators may cause interference on the vein
illuminator. Therefore, keep the vein illuminator away from
these devices when using the vein illuminator.
To avoid the risk of electric shock, connect the vein illuminator
to only the power supply system with protective earth. In case
that the power supply system does not have protective earth,
disconnect the power cable of the vein illuminator from the
power supply system and use the built-in battery to power the
vein illuminator.

Safety
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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.
This product is a class I continuous-operation device without
waterproof protection design. Do not splash or drip any liquid
onto or into the device, and do not immerse any part of the main
unit in liquid. If any liquid splashes into the product during
charging or operation of the product, immediately power off the
product and stop using it.
Only use the dedicated accessories provided by MEDCAPTAIN.
Before use, check the power cable, power adapter, and other
accessories. In case of any damage, stop using the product and
contact the after-sales service department of MEDCAPTAIN.
This product has a removable battery inside. Operate, store, and
transport this product in strict accordance with the operation
manual. Do not use the product in flammable and explosive
environment.
The lithium battery provided by MEDCAPTAIN is the original
battery. If this product will not be used for a long time, fully
charge it for storage. The service life or shelf life of the battery
is one year.
Do not discard the retired vein illuminator at will. The product
contains a battery and therefore it must be disposed of according
to the Technical Policy for Discarded Batteries Pollution
Prevention in a professional manner.

Safety
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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.
Do not apply this product on the skin with scar, tattoo, skin
disease, or lots of hairs because they may interfere with the
imaging of the product.
This product must only be used for assisting medical personnel
in vein locating or for training and teaching medical personnel
how to use it. This product is not the sole method of vein
locating and cannot completely substitute other vein locating
methods that are based on reliable medical judgments or sight
and touch judgments.
If the vein illuminator falls to the ground or it is affected by an
external force, stop using vein illuminator even if it appears
normal. Contact your local distributor and have an inspection
performed to judge whether the vein illuminator is operating
properly.
Do not service or maintain the vein illuminator or its accessory
when it is being used on a patient.
Do not try to upgrade the software of the vein illuminator. To
upgrade the software, please contact your local distributor for
help. The software upgrade must be executed by trained
technicians. Otherwise, an error of the vein illuminator may
occur. After software upgrade, the vein illuminator must be
validated by trained technicians before use.

Safety
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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.
If the vein illuminator fails to act as specified herein for
unknown reason, power it off and report the conditions when the
fault occurs to your local distributor or the after-sales service
department of MEDCAPTAIN.
Do not disassemble or reconstruct the vein illuminator without
permission.
This product requires maintenance by authorized personnel. The
authorized personnel can ask for such materials as the service
manual and list of spare parts from the manufacturer.
The power adapter is a part of the vein illuminator.
2.2 Symbol Description
Symbol
Description
CAUTION
Manufacturer
Alternating current
Refer to instruction manual/booklet
General warning sign

Safety
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Date of manufacture
Direct current
Authorized representative in the European
Community
Serial number
CE Mark: conforms to essential
requirements of the Medical Device
Directive 93/42/EEC
DISPOSAL: Do not dispose of this product
as unsorted municipal waste. Separate
collection of such waste for special
treatment is necessary.
Fragile, handle with care
Keep away from sunlight
Temperature limit
Stacking limit by number
This way up
Keep dry
Atmospheric pressure limitation
Humidity limitation

Product Specifications
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3Product Specifications
Name
Vein illuminator
Model
NAVI-30/NAVI-60
Dimensions
224 (W) x 68 (H) x 64 (D) mm
Weight
About 0.5kg
Power Adapter
Input: 100-240Vac 50/60Hz 1.5A Max
Output: 12V 3.5A
Model of the power adapter:LXCP52-012
Battery
Built-in lithium battery: 7.3V, 2750mAh
Battery model: 18650-2S1P
Continuous operation duration of the lithium
battery: not shorter than 2.5 hours
Time required for fully charging an exhausted
lithium battery: not longer than 4 hours (the
device is powered off during the charge)
Charge mode of the lithium battery: The
battery can be charged using a power adapter
when AC input is available.
Display Mode
Projection mode
Light Source
Type
Near-infrared light
Infrared
Wavelength
850nm dual light sources
Optimal Focus
Position
210mm±30mm

Product Specifications
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Depth of Field of
Imaging
>30mm
Infrared
Radiation Energy
≤0.6mW/m2
Operating
Conditions
Temperature: 5°C~40°C
Humidity: 20%~90% RH, non-condensing
Pressure altitude: 70~106.0kPa
Storage and
Shipping
Conditions
Temperature: -20°C~+55°C
Humidity: 10%~95% RH, non-condensing
Pressure altitude: 61.7~107.4kPa
Service Life
5 years
Classification
1. Class I/Internally powered equipment;
2. IPX0;
3. Not sterilized;
4. Not category AP/APG equipment;
5. Mode of operation: continuous
Date of
Manufacture
See the product label.
Main Safety
Standards
IEC 60601-1:2012 Medical Electrical
Equipment, Part 1: General Requirements for
basic safety and essential performance
IEC60601-1-2:2014 Medical Electrical
Equipment - Part1-2: General requirements
for basic safety and essential
performance-Collateral standard:
Electromagnetic compatibility-Requirements
and tests

Product Description
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4Product 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. The vein illuminator
is designed based on this principle. During use of the vein
illuminator, the reflected infrared light is perceived by the CCD.
After a series of digital image processing by the image processing
chip, the vein illuminator shows the outline image of the veins and
projects the image on the skin surface to reveal the vein distribution.
Qualified medical personnel can observe and locate the vein for
venipuncture or blood drawing according to the vein distribution
image projected on the skin surface.
4.3 Main Unit

Product Description
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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.
Running indicator: This indicator is steady green when the
device is in power-on state and extinguished when the device is
in power-off state.
Battery indicator:

Product Description
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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. In case of low battery,
the battery indicator is quickly blinking green. When the
battery is exhausted, the battery indicator is extinguished.
Power indicator: The power indicator is steady blue when the
device is connected to an external power supply. When the
device is in power-on state and not connected to any external
power supply, the power indicator is slowly blinking blue.
Power button: A user can press the power button to power on the
device. When the device is in running state, a user can press the
power button to power off the device. If the device is powered
by the battery, it will be automatically powered off if no
operation is performed within 4min.
Brightness button: A user can press this button to adjust the
projection brightness. Four brightness levels are available for
selection.
Size button: A user can press this button to switch the size of the
projection image.
Mode button: A user can press this button to switch between the
basic mode, color mode, and depth mode. In addition, a user can
press and hold this button and then release to switch the current
display color.
Basic mode: This mode is suitable for the users with different
visual feelings.

Product Description
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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 window: Used to
receive infrared light and project an
image.
2–Infrared lamp: Used to emit
infrared light.
3–Battery compartment: rear cover
of battery.

Product Description
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4.3.3 Bottom View
Power interface: Used to connect to the power adapter.
4.4 Accessories
No.
Accessory Name
1
AC power cable
2
Power adapter
3
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.

Installation Description
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5Installation 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.
No power supply interference exists.
No corrosive or flammable gas should be present.
No flammable and explosive materials should be present.
5.2 Open Package Inspection
Before opening the package, please inspect the packaging box
carefully. In case of any damage, please contact your local
distributor or the after-sales service department of the manufacturer
immediately.
1. Take the vein illuminator and accompanied accessories out of the
packaging box.
2. Check whether the accessories in the packaging box are consistent
with those on the packing list, and check whether there is any
mechanical damage on the device or its accessories. In case of any
doubts, please contact the local distributor or the after-sales
service department of the manufacturer immediately.
5.3 Connecting the Power Supply
Place the vein illuminator in an environment meeting the
requirements stipulated in section 5.1, and connect the device to an
external power supply.
1. Use the AC power cable and power adapter provided by the
manufacturer.