VE800 Operator's Manual

Shenzhen Yuanray Biomed Co., Ltd.
Vein Finder
VE800 Operator’s Manual
1
CONTENT
WARNINGS ...................................................................................................................................................... 5
CAUTIONS ....................................................................................................................................................... 6
1. DEVICE AND PACKAGE SYMBOLS ....................................................................................................... 7
2. PRODUCT OVERVIEW .............................................................................................................................. 9
3. INTENDED USE ...........................................................................................................................................9
4. CONTRAINDICATIONS .............................................................................................................................. 9
5. PACKING LIST ............................................................................................................................................ 9
6. PRODUCT APPEARANCE AND CONFIGURATION ............................................................................11
6.1 APPEARANCE AND DIMENSIONS ................................................................................................................. 11

6.2 PRODUCT CONFIGURATION ......................................................................................................................... 12
7. PANEL DESCRIPTION ............................................................................................................................. 13
7.1 BUTTON ........................................................................................................................................................13

7.2 DISPLAY INTERFACE .....................................................................................................................................14
7.3 INDICATOR .................................................................................................................................................... 15
8. UNPACKING AND VERIFICATION ......................................................................................................... 16
8.1 PRODUCT VERIFICATION ............................................................................................................................. 16

8.2 VERIFICATION METHOD ............................................................................................................................... 16
9. OPERATION INSTRUCTION ................................................................................................................... 17
9.1 CONNECTING THE POWER SUPPLY ............................................................................................................ 17

9.2 POWER ON .................................................................................................................................................. 18
9.3 SETTING THE MODE .................................................................................................................................... 18
9.4 USAGE ..........................................................................................................................................................18
9.5 IMAGE CAPTURE AND EXPORT .............................................................................................................................. 20
9.6 SLEEP ...........................................................................................................................................................21
9.7 POWER OFF .................................................................................................................................................21
10. ERROR AND PROMPT .......................................................................................................................... 22
11. CLEANING AND DISINFECTION ..........................................................................................................24
12. STORGE AND TRANSPORTATION ..................................................................................................... 25
13. WARRANTY AND LIMITATION OF LIABILITY ................................................................................... 26
13.1 PRODUCT WARRANTY ............................................................................................................................... 26

13.2 DISCLAIMER ............................................................................................................................................... 26
13.3 ABOUT BATTERIES .....................................................................................................................................26
14. SPECIFICATION ......................................................................................................................................27
15. EMC ...........................................................................................................................................................28
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Manual Information
P/N: H-4101-00002-01
Release date: August 2023
Revision: 1.0
© Copyright 2023 Shenzhen Yuanray Biomed Co., Ltd. All rights reserved.
Product Information
Product Name: Vein Finder
Model: VE800
Service life: 5 years (Except battery)
Statement
Shenzhen Yuanray Biomed Co., Ltd. (hereinafter called “the company”) owns the copyright to this
manual and reserves the right to treat it as confidential information. This manual can only be used
as a reference for the operation, care and maintenance of our products. No other person is entitled
to disclose the content of this manual to others.
This manual contains proprietary information protected by copyright law. No part of this manual
may be reproduced, modified or translated by any person or organization without the written
consent of the company.
All contents of this manual are considered correct. The company does not assume any legal
liability for errors in this manual, as well as accidental or inevitable damages caused by incorrect
installation or improper operation. The company does not provide any franchise rights granted by
patent law to other parties. The company shall not be liable for any legal consequences arising
from the violation of patent law or any third-party rights.
This manual is subject to change without prior notice.
Manufacturer’s Responsibilities
The company is responsible for the safety, reliability and effectiveness of the product only when all
the following requirements are met:
 Assembly operation, expansion, readjustment, improvement, and repair are conducted by the
company authorized professionals.
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 All replacement parts, accessories and consumables involved in the maintenance are
provided by or approved by the company. The relevant electrical equipment complies with the
international standards and the requirements of this manual.
 The product is operated in accordance with the operator’s manual.
Operator’s Manual
Before reading this manual, the user should carefully understand and pay attention to the following
information:
Warnings
Remind the operator to follow the instructions under the symbol, otherwise it may cause personal
injury, product malfunction or damage, or affect the test results.
Cautions
Prompt the operator to follow the instructions under the symbol, emphasizing the important
information in the operation procedure or the content to be paid special attention by the operator.
Contact Information
B1102-B1106, No. 196 Tangtou Avenue, Langxin Community, Shiyan Street, Baoan District,
Shenzhen 518000, P.R.China
Tel: 400-101-1389
E-mail: contact@yuanray.com.cn
Website: www.yuanraybio.com
WellKang Ltd.
Enterprise Hub, NW Business Complex,1 Beraghmore Road, Derry, BT48 8SE, Northern Ireland
Tel1：+44(33)3303 1126
Tel2：+44(20)3287 6300
Website: www.CE-Marking.eu
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Warnings
 Read this manual carefully before using the product.
 The product should be installed and used according to the information provided in the
accompanying documents.
 Please use special accessories provided or approved by the company. Check whether the
power cord, adapter and other accessories are damaged before use. If yes, please do not use
them and call our customer service department.
 This product is a Class I continuous operation device.In order to avoid the risk of electric
shock, please connect the equipment to the power supply system with protective grounding. If
the power supply system does not have protective grounding, disconnect the power cable
from the power supply system and use the built-in battery to power the device.
 It is prohibited to spill or immerse any part of the product in liquid. If liquid splashes into the
product during charging or use, please power off the product immediately and stop using it.
 Please operate, store and transport the product in strict accordance with the operator’s
manual. Do not use the product in an environment where flammables and explosives exist.
 Users are not allowed to replace the batteries on their own. To replace the batteries, mail the
main unit to the device manufacturer or contact the device manufacturer or regional distributor
for service personnel to replace. Do not disassemble the batteries on your own to avoid safety
risks.
 Do not open, disassemble, or repair lithium batteries by yourself. Do not squeeze, puncture,
or discard the battery in fire or water.
 Do not short-circuit the positive and negative poles of the battery. Do not expose the battery to
temperature above 60℃.
 Do not discard the device if it is scrapped. The device contains battery, which should be
handled professionally in accordance with local laws or regulations.
 The device has laser radiation, do not stare into the laser beam.
 The vein display is related to the patient’s physical factors. If there are wounds, tattoos, skin
diseases, excessive hair, and obese tissues on the skin surface of the area to be observed,
the image of the device will be interfered. Avoid using the above areas.
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 This product is intended only for qualified medical personal to assist in finding and observing
the vein, or for training and demonstration of medical personnel, and is not intended to
replace the medical judgment based on visual and tactile vessel locating.
Cautions
 This device complies with IEC 60601-1:2005+A1:2012+A2:2020 Medical electrical equipment
– Part 1: General requirements for basic safety and essential performance.
 This device complies with IEC 60825-1:2014+A2:2020 Safety of laser products – Part 1:
Equipment classification and requirements.
 This device complies with IEC 62471:2006 Photobiological safety of lamps and lamp systems.
 This device complies with the EMC requirements of IEC 60601-1-2:2014+A1:2020.
 This device complies with the requirements for Group 1, Class A of CISPRR 11.
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1. Device and Package Symbols

The symbols on the device and package are shown in the table below:
Symbol Meaning Symbol Meaning
Date of manufacture General Warning Sign
Manufacturer Caution
Serial number Unique device identifier
Refer to instruction
Use by date
manual/booklet
Direct current Laser label
Authorized
Medical Device representative in the
European Community
Temperature limit Humidity limitation
Atmospheric pressure
This way up
limitation
Fragile, handle with Keep away from

care sunlight
Stacking limit by
Keep away from rain
number
This product is The following definition

provided with a CE of the WEEE label
marking in accordance applies to EU member
with the provisions of states only: This
the Regulation (EU) symbol indicates that
2017/745 on medical this device must not be
devices. disposed of as
The device complies unsorted municipal
with the Directive waste and must be
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2011/65/EU, amended collected separately.

by Directive For more detailed
2015/863/EU. information with regard
to returning and
recycling this device,
please consult the
distributor from whom
you purchased it.
Table 1 Device and Package Symbols
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2. Product Overview
VE800 is a hand-held vein finder, which utilizes the difference of absorption of near-infrared light
by hemoglobin in the subcutaneous superficial venous blood vessel of human body. The NIR
enhanced CMOS module is used to image the superficial skin. After being processed by the
vascular enhancement algorithm, the processed venous image is displayed on the superficial
skin by laser scanning in situ to assist the medical personnel in performing venipuncture
operations such as transfusion and blood drawing.
The vein finder can assist the medical staff in finding the vein or demonstrate the training of the
medical staff. This is not the only method of vascular search, nor a complete replacement of
methods of vascular search based on reliable medical judgement as well as visual and tactile
judgement, VE800 can only display superficial veins. The image quality depends on the patients’
physical conditions, such as vein depth, skin eczema, tattoo, scar, hair on the skin, and
obesity-shaped tissue.
3. Intended Use
The vein finder is intended used to observe and search the superficial subcutaneous vein, and
assist the medical staff in performing venipuncture operations such as transfusion and blood
drawing.
4. Contraindications
 This product is forbidden for use in eyes and peripheral veins.
 This product can only identify superficial veins, which cannot be effectively evaluated for
arteries.
 Do not use this product as a diagnostic device or for any therapeutic purpose.
5. Packing List
 Main unit: 1pcs
 Power adapter: 1pcs

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 AC power cord: 1pcs
 USB cable: 1pcs
 Operator’s manual: 1pcs
 Accuracy test card: 1pcs
 Qualification certificate: 1pcs
 Warranty card: 1pcs
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6. Product Appearance and Configuration

6.1 Appearance and Dimensions
Figure 1 Appearance and Dimensions of the Product
Infrared Lamp
Projection Window
Infrared Lamp
Display Screen
Ambient Light Sensor
Buttons
Battery Compartment
Front View Back View
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Side Decorative Strip
Power Port
Side View Bottom View
6.2 Product Configuration
This product consists of the main unit and accessories. The main unit consists of the control unit,
display screen, infrared light source, image sensor, projection module, internal light path module,
and lithium battery. The accessories include the power adapter.
This product is not in contact with patients.
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7. Panel Description
Display Screen
Brightness Button
Power Indicator Battery Indicator
Size Button Mode Button
Power Button
Figure 2 Interface and Button Layout
7.1 Button
Button Name Button Icon Operation and Description

Short press the Power Button to power on the device. The
Power Button device starts projection in about 10 seconds.
Long press the Power Button to shut down the device.
Short press the Brightness Button to adjust the brightness.
Brightness
Long press the Brightness Button to achieve the reverse color
Button
function of the projected image.
Short press the Size Button to adjust the projection size.

Size Button
Long press the Size Button to turn on/off infinite mode.
Short press the Mode Button to set the projection mode. You
can set the basic mode, enhancement mode and depth mode.
Mode Button Long press the Mode Button to execute image capture. When
the Mode Button is released, the device automatically saves the
current original image and processed projection image.
Figure 2 Function Description of Buttons
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7.2 Display Interface
Icon Name Main Interface Icon Description

Product
Indicates the product model.
Model
Indicates that the battery capacity is 5%-20%.
Battery Icon Indicates that the battery capacity is 60%-80%.
Indicates that no battery is installed.
Indicates battery is charging.
Brightness Indicates the current projection brightness. Level 1 is
Icon the weakest and Level 4 is the strongest.
Indicates the current size is normal, projecting a large
image.
Size Icon
Indicates the current size of a child, projecting a small
image.
Indicates that it is currently in basic mode, which is
suitable for people with different visual sensations.
Indicates that it is currently in enhancement mode,
Mode Icon which enhances the visibility of the blood vessels.
Indicates that it is currently in depth mode, which can
prompt the venous depth information and assist
medical staff to adjust needle insertion.
Indicates that the reverse color mode is turned off,
with blood vessels in black and a background in
Reverse green.
Color Icon Indicates that the reverse color mode is turned on,
with blood vessels in green and a background in
black.
Indicates that the infinite mode is turned off, and the
device will shut down automatically when it enters
sleep mode for 10 minutes without any operation.
Infinite Icon
Indicates that the infinite mode is turned on, and the
device will not shut down automatically when it enters
sleep mode without any operation.
USB Icon Indicates that the USB disk is connected to the device.
When an error occurs, the error icon and code are

Error Icon displayed. For detailed error code information and
troubleshooting , please refer to the “Error and
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Prompt” section.
Capture Icon It prompts that the image is captured successfully.
Export Icon It prompts that the image is being exported.
Sleep Icon Indicates that the device is in sleep mode.
Figure 3 Description of Main Interface Icon
7.3 Indicator
 Power Indicator ：
 The power indicator is steady on when the power adapter is connected;
 The power indicator is off when the power adapter is disconnected.
 Battery Indicator ：
 The battery indicator is normally on during startup;
 When the device is connected to the power adapter in working status, the battery is
being charged and fully charged, and the battery indicator is stead on, if charging is
abnormal, the battery indicator flashes;
 In working status, if the device is not connected to a power adapter and powered by
the battery, the battery indicator remains on. When the battery is low, the battery
indicator flashes. When the battery is exhausted, the device will be shut down, and
the battery indicator is off.
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8. Unpacking and Verification

8.1 Product Verification
This product belongs to medical auxiliary equipment. When the device is used for the first time or
after transportation, the medical personnel should use an accuracy test card to verify the device
accuracy.
8.2 Verification Method
Place the accuracy test card in the projection area of the main unit, and verify the deviation
between the projection image and the test card image at the optimal imaging position (the
distance between the projection holes of the test card is 210±30mm). If the deviation is less that
1 mm (can be measured with a calibrated ruler), the device can be used normally. If the deviation
is larger than 1 mm, stop using and contact our customer service department or your local
distributor.
Figure 3 Accuracy Test Card
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9. Operation Instruction
9.1 Connecting the Power Supply
This product can be used directly by hand, or mounted on a trolley and connected to the external
power supply.
Connect an external power supply as follows:
1. Connect AC power cord to the power adapter;
2. Connect DC output plug to the power port at the bottom of the vein finder;
3. Connect the AC plug to the matched AC power socket.
Warnings
 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. Otherwise, an accident may occur.
 Use the AC power cord provided by the manufacturer to ensure that the device is properly
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grounded. If the device is not properly grounded, the safety performance cannot be
guaranteed and an electric shock may occur.
 The plug of the AC power cord must be firmly and fully inserted into the power socket.
 Do not use the power socket that is difficult to be disconnected from the power plug.
Cautions
 The battery is charging when the device’s power adapter is connected to power supply.
 When the battery level is low, connect an external power supply to charge the battery.
9.2 Power On
Short press the power button to power on the device, the display screen is on, and the device
starts to project in about 10 seconds.
9.3 Setting the Mode
You can set the following modes according to your requirements. For the meanings of each
mode, see section 7.2.
Short press the Mode Button to set the projection mode. You can set the basic mode,
enhancement mode and depth mode.
Short press the Size Button to set the projection size. You can set the large size and small size.
Short press the Brightness Button to set the projection brightness. You can set the brightness as
level 1 - level4.
Long press the Brightness Button to enable or disable the reverse color mode.
Long press the Size Button to turn on or turn off the infinite mode.
9.4 Usage
Place the device at a height between 180mm and 240mm away from the superficial skin,
observe the projection image, select the targe vein region.Once a vein is selected, make sure the
vein display light is centered directly above the vein’s center line. If there is a certain tilt between
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the device and the target vessel, there will be a deviation between the projection and the center
of the target vessel.
Proper adjustment of the distance between the device and the superficial skin can improve the
sharpness of the projection image, so as to better observe the vessel position.
In depth mode, align the long side of the center cross in the same direction of the vein projection.
Green strip indicator will be showed at top of the projection window. Different type of Green strip
indicator’s meanings are as follows.
One-strip green indicator: The vein depth is approximately 0~2 mm (shallow).
Two-strip green indicator: The vein depth is approximately 2~4 mm (deep).
Three-strip green indicator: The vein depth is approximately 4~6 mm (deeper).
Warnings
The depth mode is for reference only and shall not be used as clinical judgment for actual vein
depth.
Cautions
 Check the accuracy of the device according to section 8.2. After that, the device can be used
to observe the superficial veins.
 To accurately visualize the target vessel, the device should be positioned in the center of the
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target vessel.
 When the device is placed in the optimal distance, the width of the projection vessel is closer
to that of the target vessel.
 You can adjust the brightness button to change the brightness of the projection image to
match the ambient light intensity. If the ambient light intensity is too strong, such as bright
sunlight, the projection image may not be visible.
 If the projection is obscure or there are obvious spots, the glass of the projection window may
be dirty. Clean the glass of the projection window according to the cleaning methods in
chapter “Cleaning and Disinfection” in this manual.
 When the device is hit suddenly or in a sudden movement, the projection image disappears
for about 5 seconds, and then recovers.
 If the device does not perform any operation for 10 minutes, or if the device detects weak
ambient light, or if the power button is pressed, the device will enter the sleep mode. You can
press any button shortly to exit the sleep mode. In the sleep mode, the device will not project
image.
 When the device battery level is lower than 10%, the battery indicator flashes. In this situation,
there might be no projection when the device exits sleep mode.
 When the battery level of the device is lower than 5%, the device will automatically shut down
in 30 seconds. In this case, the device may not be started normally, or the screen display is
normal without projection image.
 If the device is used in the environment higher than the upper limit of the operation
temperature for a long time, the image may not be projected properly.
9.5 Image capture and export
If you need to capture current image, please place the device at a height between about 180mm and
240mm from the object , long press the mode button, when you release the mode button, the device
will pop up the capture icon, prompting that the capture is successful.
If you need to export images, you need to open the battery cover, connect the USB disk to USB
interface through the USB data cable, when the USB icon appears on the main interface, long press the
mode button for a long time, when you release the mode button, the device will pop up the export icon,
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when the export icon disappears, the image export is completed. Take off the USB disk and USB data cable,
and put on the battery cover.
Cautions
 When capturing the image, please keep the device and the object stable to avoid blurring the image.
 During the process of exporting images, do not remove the U disk, otherwise the export will fail.
9.6 Sleep
The device will enter the sleep mode and stop projection in the following cases:
 The ambient light is very weak or the device is placed on a table
 Short press the Power Button
 The device is turned on for more than 10 minutes
Press any button to exit sleep mode and restart the projection function.
When the infinite mode is switched on, the device enters the sleep mode until the user press any
button to exit the sleep mode. Otherwise, the device will always in the sleep mode.
When the infinite mode is turned off, the device enters the sleep mode, if there is no operation
within 10 minutes, the device will be turned off automatically.
9.7 Power Off
Long press the Power Button for more than 5 seconds to power off the device.
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10. Error and Prompt

The definition and troubleshooting of the device error code are shown in the table below:
Error
Definition Possible Cause Troubleshooting
Code
Please shut down the device and
disconnect it from charging. After the
Processor temperature of the processor returns to
Excessive ambient
1 temperature too normal , recharge or restart it.
temperature
high If your attempt fails, contact our local
distributor or our customer service
department.
Projection module temperature of the processor returns to
Excessive ambient
2 temperature too normal , recharge or restart it.
temperature
high If your attempt fails, contact our local
department.
temperature of the processor returns to
Battery temperature Excessive ambient
3 normal , recharge or restart it.
too high temperature
If your attempt fails, contact our local
department.
Please shut down and restart the device.
Projection module Projection module If your attempt fails, contact our local
4
abnormal failure distributor or our customer service
department.
If your attempt fails, contact our local
5 CMOS abnormal CMOS fault
department.
The ambient light
The ambient light If your attempt fails, contact our local
6 sensor goes
sensor is abnormal distributor or our customer service
wrong.
department.
Contact your local distributor to replace
7 Poor battery status Battery life expired
the battery.
Figure 4 Error Code and Resolution Measures
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Cautions
 When the device is malfunction , the error code appear in the upper middle area of the display,
and the buzzer rings three times.
 When error code 1/2/4/5 occurs, there is no projection image on the device, and the device
recovers after the error is solved.
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11. Cleaning and Disinfection

To sustain the working life and stability of the product, the main unit should be cleaned and
maintained regularly.
When the device is powered off, use a dray cloth dipped with 75% medical alcohol or
Benzalkonium bromide solution to wipe the device housing.
The optical windows of the device, such as the infrared light source window, the projection
window and the ambient light sensor window, must be kept clean to ensure normal operation of
the device. If the projection window glass is dirty or scratched, the projection image will be
blurred.
Wipe the optical window with the lens paper. Wipe the glass surface with a few drops of ethanol
along one direction of the glass.
Warnings
 Do not immerse the device in cleaning solution or disinfectant for disinfection.
 Do not use radiation or steam to disinfect the device or accessories.
 Do not clean or disinfect the device when it is on.
 Do not clean or disinfect when the battery cover is removed.
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12. Storge and Transportation

Environment
Operation Storage Transportation
Conditions
Temperature 5℃～33℃ -20℃～55℃ -20℃～55℃
30%~85%, 10%~90%, 10%~90%,
Relative Humidity
non-condensing non-condensing non-condensing
Atmospheric
70-106kPa 70-106kPa 70-106kPa
pressure
Warnings
 This product is a medical device. To ensure the working life and accuracy of the device, the
user should store and transport the device according the above environment conditions.
 Excessive humidity might cause the device to malfunction. Excessive vibration during the
transportation might cause the device components to be damaged.
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13. Warranty and Limitation of Liability

13.1 Product Warranty
 For details, refer to the warranty card in the accessory package.
13.2 Disclaimer
 Without the authorization of the company, the company shall not bear any legal liability for the
adverse consequences caused by the disassembly of the device by the user. Users and
suppliers have the right to request the company to provide relevant user instruction and
technical services.
 The company shall not be responsible for accident that caused by the unintended use of the
the product, or unqualified users that misoperate the equipment.
 The company shall not be responsible for medical disputes arising from the customer's
lending to a third party or renting to another organization through abnormal procedures.
13.3 About Batteries
 This product uses 3.7V 6700 mAh high performance rechargeable lithium batteries.
 As the frequency of use increases, the battery life and endurance will be gradually decreased.
 The battery life depends on the working time, device temperature, and number of charge
cycles.
 Lithium battery provided by the company are original . If this device is not used for a long time,
please fully charge and store it.
 After two or three years of normal use, replace the battery.
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14. Specification
Technical Parameters Content
Projection principle Laser scanning projection
Imaging wavelength 850nm
Display wavelength 520nm
Display Screen 1.44 inches, 128 pixels ×128 pixels
Optimal focus position 210mm±30mm
Infrared radiation energy ≤0.6mW/cm2 @optimal focus position
Laser safety class Class 1(IEC 60825-1:2014)
Input: AC 100-240V 50/60Hz

Power adapter
Output: DC 12V 3.34A
Lithium battery DC 3.7V 6700mAh
Rated power 5VA
Battery life ≥4h
Charging time 5% to 100%, ≤3h
Net weight of product 420g
Product dimension 230mm*65mm*60mm
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15. EMC
Warnings
 Use of accessories, transduces and cables other than those specified or provided by the
manufacturer of this device could result in increased electromagnetic emissions or decreased
electromagnetic immunity of this device and result in improper operation.
 Use of this device adjacent to or stacked with other device should be avoided because it
could result in improper operation. If such use is necessary, this device and the other device
should be observed to verify that they are operating normally.
 Portable RF communications equipment (including peripherals such as antenna cables and
external antennas) should be used on closer than 30 cm (12 inches) to any part of this device,
including cables specified by the manufacturer. Otherwise, degradation of the performance of
this device could result.
 The non-ME EQUIPMENT (e.g. ITE) that is a part of an ME SYSTEM may be disrupted by the
electromagnetic interference of nearby equipment. It may be necessary to take mitigation
measures, such as re-orienting or relocating the non-ME EQUIPMENT or shielding the
location.
 The is device is intended for use in professional healthcare facility environment only. If it is
used in special environment, such as magnetic resonance imaging environment, the
equipment/system aby be disrupted by the operation of nearby equipment.
 The device needs special precautions regarding EMC and needs to be installed and put into
service according to the EMC information provided below.
 Use of portable or mobile communications devices will degrade the performance of the
device.
 Other devices may affect this device even though they meet the requirements of CISPR.
 If the essential performance is lost or degraded, it may be necessary to take mitigation
measures, such as re-orienting or relocating the ME EQUIPMENT or ME SYSTEM or
shielding the location or stopping using the device and contact the service personnel.
Guidance and Declaration – Electromagnetic Emission

VE800 is intended for use in the electromagnetic environment specified below. The customer or the user of VE800
should assure that it is used in such an environment.
Emission test Compliance Electromagnetic environment – Guidance
RF emissions Group 1 VE800 uses RF energy only for its internal function.
CISPR 11 Therefore, its RF emissions are very low and are not
likely to cause any interference in nearby electronic
device.
RF emissions Class A VE800 is suitable for use in all establishments other
CISPR 11 than domestic and those directly connected to the
public low-voltage power supply network that supplies
buildings used for domestic purposes.
Harmonic emissions Not applicable /
28
IEC 61000-3-2
Voltage Not applicable /
fluctuations/flicker
emissions
IEC 61000-3-3
If the device is operated within the electromagnetic environment listed in Table Guidance and
Declaration – Electromagnetic Immunity, the device will remain safe and provide the following
essential performance:
 Operating mode
 Accuracy
 Function
Guidance and Declaration – Electromagnetic Immunity

VE800 is intended for use in the electromagnetic environment specified below. The customer or the user of VE800
should assure that it is used in such an environment.
Electromagnetic environment
Immunity test IEC 60601 test level Compliance level
- guidance
Electrostatic ±8 kV contact ±8 kV contact Floors should be wood, concrete
discharge ±2,4,8,15 kV air ±2,4,8,15 kV air or ceramic tile. If floors are
(ESD) covered with synthetic material,
IEC 61000-4-2 the relative humidity should be
at least 30%.
Electrical fast ±2 kV for power supply ±2 kV for power supply lines Mains power quality should be
transient/burst lines that of a typical commercial or
IEC 61000-4-4 ±1 kV for input/output lines ±1 kV for input/output lines hospital environment.
Surge ±1 kV line(s) to line(s) ±1 kV line(s) to line(s)
IEC 61000-4-5 ±2 kV line(s) to earth ±2 kV line(s) to earth
Voltage dips, <5% UT >95% dip for <5% UT >95% dip for Mains power quality should be
short 0.5 cycle 0.5 cycle that of a typical commercial or
interruptions 40% UT 60% dips 40% UT 60% dips hospital environment. If you
and voltage 70% UT 30% dip 70% UT 30% dip require continued operation
variation on during power mains
power supply interruptions, it is recommended
input voltage that VE800 be powered from an
IEC 61000-4-11 uninterruptible power supply or a
battery.
Power Power frequency magnetic fields
frequency should be at levels characteristic
(50 Hz/60 Hz) 30A/m 30A/m of a typical location in a typical
magnetic fields commercial or hospital
IEC 61000-4-8 environment.
Note: UT is the A.C. mains voltage prior to application of the test level.
29
Guidance and Declaration – Electromagnetic Immunity

The vein finder is intended for use in the electromagnetic environment specified below. The customer or the user of
the device should assure that it is used in such an environment.
Immunity test Immunity test Immunity test Immunity test
Conducted RF 3Vrms 3Vrms Portable and mobile RF communications equipment
IEC 61000-4-6 150 kHz-80MHz should be used no closer to any part of VE800, including
cables, than the recommended separation distance
calculated from the equation applicable to the frequency
of the transmitter. Recommended separation distance:
d = [3.5/3] � 150 kHz-80MHz
d = [3.5/3] � 80MHz-800MHz
d = [7/3] � 800MHz-2.5GHz
where P is the maximum output power rating of the
Radiated RF 3 V/m 3 V/m
transmitter in watts (W) according to the transmitter
IEC 61000-4-3 80MHz-2.7GHz
manufacturer and d is the recommended separation
distance in meters (m).
Field strengths from fixed RF transmitters, as determined
by an electromagnetic site surveya, should be less than
the compliance level in each frequency rangeb.
Interference may occur in the vicinity of equipment
marked with the following symbol:
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.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with
accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey
should be considered. If the measured filed strength in the location in which the vein finder is used exceeds the
applicable RF compliance level above, the vein finder should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as re-orienting or relocating the vein
finder.
b Over the frequency ranges 150 kHz to 80 MHz, field strengths should be less than 3V/m.
Recommended Separation Distances between Portable and Mobile RF, Communications Equipment and
the Vein Finder
The vein finder is intended for use in an electromagnetic environment in which radiated RF disturbance are
controlled. The customer or the user of the vein finder can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and
the vein finder as recommended below, according to the maximum output power of the communication equipment.
30
Rated Maximum Separation Distance According to Frequency of Transmitter (m)

Output power of 150kHz to 80MHz 80MHz to 800MHz 800MHz to 2.5GHz
Transmitter (W) 3.5 3.5 7

d=[ ] P d=[ ] P d=[ ] P
V1 V1 E1
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters at a maximum output power not listed above, the recommended separation distanced in meters
(m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum
output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
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.
Cable information
Cable Name Cable Length (m) Cable Shielded (Y/N)
AC power cable 1.75m N
Power adapter 1.00m N
31

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Shenzhen Yuanray Biomed Co., Ltd.