AccuVein AV500 User manual

A health professional’s guide for use
and operation of the AccuVein AV500
AccuVein AV500 User Manual
English

520nm / 830nm
485nJ / 270nJ
EN/IEC 60825-1:2014
AccuVein® is the registered trademark of AccuVein Inc.The content of this manual
including all photographs and drawings is the proprietary information of AccuVein Inc.
This manual last revised: January 2019
Warnings and Cautions
Read all instructions, cautions, and warnings prior to use.This product should be operated
only by qualied medical professionals.The AV500 should not be used as the sole vein
location method, and it is not a substitute for sound medical judgment and the visual and
tactile location of veins.
Before using the AV500 on a patient, qualied medical professionals must read and
understand this AV500 User’s Manual. Before rst use, users should compare how the
AV500 detects veins with visual detection and palpation techniques.
AV500 is manufactured for AccuVein Inc.
2797
Device fully complies with
European Directive 2002/364/
EC. Conformité Européenne
Australian Sponsor:
Emergo Australia
Level 20,Tower II
Darling Park
201 Sussex Street
Sydney, NSW 2000
Australia
EMERGO EUROPE
Prinsessegracht 20
2514 APThe Hague
The Netherlands
This AV500 User Manual and additional information can also be
downloaded from www.accuvein.com
AccuVein Inc.
3243 Route 112
Bldg. 1 Ste 2
Medford, NY 11763
United States of America
www.accuvein.com
Phone: [phone]
IEC/EN 60825-1:2014
Class 1 laser device
Wavelength: 520nm and 830nm
485nJ and 270nJ per pulse in train
For United States of America customers: Complies with 21 CFR 1040.10 and 1040.11
except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007
Basicuse
andoperation 5
Setup
Intended Use
Product Description
Charging,cleaning,
and disposal 8
Charging the AV500
Cleaning and Disinfecting
Disposal
Troubleshooting
andService 11
Alerts
Faults
Product Label
Specications 14
Labeling
Specifcations
Environment
User Manual
A health professional’s guide for use and
operation of the AccuVein AV500
English
AV500

Safety Alert. Indicates a potential personal injury hazard
Warning: Indicates a hazardous situation, which if not
avoided, could result in death or serious injury
Caution: Indicates a hazardous situation that if not avoided
may result in minor or moderate injury.
Refer to instruction manual
Laser light
The AV500 emits laser radiation
Type B Applied Part
Conformité Européenne (European Conformity). This
symbol means that the device fully complies with European
Directive 93/42/EEC
ETL Classied means that most system elements conform
to IEC standard 60601-1
Product Serial Number
Reference to Catalog Model Number
European Representative
Manufacturer
European Union Waste Electrical and Electronic Equipment
Directive Logo. Return is allowed for proper disposal.
Temperature limitation
Humidity limitation
Do not use if package is damaged
Keep dry
Fragile, handle with care
Reusable packaging
Recyclable packaging
Direct Current. Example: 5.0 V indication of charging
voltage
Manufacturing date
Symbols

Warnings and Cautions
Patient and User Safety—Warnings
WARNING:The AV500 enables location of certain supercial veins and is not
a substitute for sound medical judgment based on the visual and tactile location and
assessment of veins. The AV500 should be used only as a supplement to the judgment
ofaqualied professional.
WARNING:The AV500 should only be operated when its battery is suciently
charged (indicatedwhen the battery iconon theLCDscreenisgreen),orwhenthe device
is operatedin a powered hands-freeaccessory toensure AV500 isavailableforuse.
WARNING: AV500veinlocation isdependenton a varietyofpatientfactorsand
may not display veins on patients with deep veins, skin conditions, hair, scarring or other
highlycontoured skin surface, and adipose (fatty)tissue.
WARNING:TheAV500 displaysonlysupercialveinsand does soonlytolimited
depthsdependent onavarietyofpatientfactors.TheAV500doesnotindicateveindepth.
WARNING: The AV500 emits Visible and Invisible laser radiation. Do not stare
intobeam.
WARNING: Stop using the AV500 if the green light does not turn on when the
sidepurplebutton is pushed.
WARNING: Do not hold the AV500 while performing venipuncture or other
medical procedures.
WARNING:Forexternal useonly.
WARNING:Keep the AV500 and its batteryout of the reach of children.
WARNING: Toviewveinlocation accurately,youmustpositiontheAV500directly
over the center ofthe veinbeing assessed.
Patient and User Safety—Contraindications
WARNING:The AV500 shouldnot be used to locate veins intheeyes.
WARNING:The AV500 is not intended to be used as a diagnostic device or for
treatment of anykind.
Patient and User Safety—Cautions
CAUTION: United States Federal law restricts this device to sale by or on the order of a
physician or otherqualied medical professional.
CAUTION:Operationoruseofthe AV500inamannerdierentthanspeciedinthisAV500
User’sManual mayresult in hazardouslaser light exposure.
Equipment Care—Warnings
WARNING:Do notimmersetheAV500ortheAV500chargingcradle in liquid or
wet the AV500 such that liquidspills o.
WARNING: Do not attempt to open, disassemble, or service the battery pack.
Do not crush, puncture, or dispose of the battery in re or water. Do not short external
contacts. Do notexpose totemperature above 60°C / 140°F.
WARNING: Do not modify in any way the interior or exterior components of
the AV500.
WARNING: To reduce the risk of re or shock hazard and interference, use only
the recommended accessoriesanddo notexposethisequipment to rainor heavymoisture.
WARNING: UseonlyAccuVeinaccessories andreplacementpartswiththe AV500.
The use ofnonAccuVein accessoriesmay degradesafety.
WARNING: Use ofthisequipmentadjacent toorstacked withotherequipment
should be avoided because it could result in improper operation. If such use is necessary,
this equipment and the other equipment should be observed to verify that they are
operatingnormally.
WARNING: Use of accessories other than those specied or provided by the
manufacturer of this equipment could result in increased electromagnetic emission,
decreased electromagneticimmunityofthis equipmentor resultinimproperoperation.
WARNING:PortableRFcommunicationsequipment(includingperipheralssuch
asantenna cablesand external antennas)shouldbe usednocloserthan30cm to anypart
ofthe AV500,CC500 orHF570.Suchequipmentuseinconsistentwiththis recommendation
could result indegradation ofthe product performance.
Equipment Care—Cautions
CAUTION: Use only AccuVein approved and branded battery charging accessories and
additionalaccessories.
CAUTION: ElectromagneticInterference (EMI) canaect theproper performance of the
device. Normal operation can berestored by removing the sourceof the interference.
CAUTION: Do not attempt to sterilize the AV500 with heat or pressure sterilization
methods.
CAUTION: The AV500 will not display veins if operatedoutside its temperature range.
CAUTION:TheAV500maynotdisplayveinsifoperated under brightlight suchas sunlight.
CAUTION: Do notdisassemble ormodifythe AV500or anyof itschargingaccessories.
CAUTION:Donotself-service.TheAV500containsnocustomerserviceablecomponents.
The AV500 and its accessories should be serviced only by an authorized AccuVein repair
department.
4

Basic use and operation
Setup
The AV500 needs to be placed in the charging cradle before
rst use. AccuVein recommends fully charging the AV500 at
that time. Connect the charging cradle to the power supply.
TheAV500comeswithpowersupply adaptors to ensureoutlet
compatibility. If necessary, secure a dierent power adaptor
to the power supply before plugging it into an outlet. The
AV500 is compatible with all voltages from 100 – 240VAC.
Remove the plastic protective cover from the AV500 display
screen before use.
Intended Use
The AccuVein AV500 is a portable, hand-held instrument
that helps medical professionals to locate certain supercial
veins. The AV500 is intended to be used as a supplement
to appropriate medical training and experience.The AV500
should not be used as the sole method for locating veins,
and should be used only by a qualied medical professional,
who should do so either prior to palpation to help identify
the location of a vein, or afterwards to conrm or refute the
perceived location of a vein.When using the AV500, medical
practitioners should always follow the appropriate medical
protocols and practices as required by their medical facility,
as well as exercise sound medical judgment.
Whenusedproperly, the AV500 enables users to locatecertain
supercialveinsinconnection with medical procedures,such
as venipuncture.
The AV500 can be used whenever the determination of vein
location is appropriate such as hospitals and clinics.
Product Description
The AV500 operates by using infrared light to detect veins
beneath the skin, then projecting the position of the veins
on the skin surface directly above the veins. Qualied medi-
cal personnel can observe the vasculature as displayed to
assist them in nding a vein of the right size and position
for venipuncture and other medical procedures requiring
the location of supercial veins. No training is required to
operate the AV500.
The AV500 only shows supercial vasculature.The maximum
depth that veins are displayed varies by patient. In addition,
some patients’veins or a portion of their veins might not be
displayed well or at all. Causes for less than optimal or lack
of vein display include, but are not limited to, vein depth,
skin conditions (e.g., eczema, tattoos), hair, scarring or other
highly contoured skin surface, and adipose (fatty) tissue.
When held directly overhead, the AV500 accurately locates
thecenter of a vein. Increasingthedisplacementfromdirectly
overhead results in an oset in the displayed vein position.
Width of displayed vein may dier from the actual width
depending on patient to patient dierences and vein width.
The center line of the vein is accurate when the device is
being used correctly and should always be used as the target
when performing venipuncture or other medical procedures.
The AV500 requires no routine or preventative maintenance.
The AV500 is portable, internally powered by battery and
approved for continuous operation.The AV500 is considered
aType B applied part.
ThetechnologyintheAV500ispatented.Visitwww.accuvein.com
for the most current information.
5

Basic use and operation
AV500 controls at a glance
Operate the device
Inverse setting
Left button
The inverse setting inverts the vein projection such that the veins can be depicted by either green
light over veins or darkness over veins and green light where veins do not appear. Changing the
inverse setting may improve vein visibility and eye comfort level. Use the left button to invert the
projection.
Projection intensity
Middle button
1 Low
2 Normal
3 Bright
The brightness of vein projection can be controlled using the brightness button.
Time-out setting
Time before unit automatically shuts o
Right button
10 minute time out
∞ no time out
The time-out setting determines the amount of time until the vein display light turns o. This
setting may help increase battery operation time of the AV500. To set the time, press the right
button to go into the time-out menu. The time out can be set to ∞ (no time-out) or 10 minutes.
Power on/o – side button
The purple button located on the left side of the AV500 will
power on the AV500 and turn on the vein display light. Press
the button again to turn the vein display light and device o.
Press the purple side button again to turn the vein display
light back on and begin locating veins again.
6

Basic use and operation
Positioning the AV500
Holdthe devicefrom6 – 10"(150 to250 mm) overthesurface
of the skin. Scan the area of interest to view. Once a vein is
selected, make sure the vein display light is centered directly
above the vein’s center line.Tilting the device to either side
of the vein will oset the projected vein from its true loca-
tion beneath the skin.You can often enhance display quality
by slightly adjusting the height and angle to the skin. In
particular, moving the device closer or further from the skin
can help bring additional veins into view, depending on the
patient’s vasculature, room lighting, and depth of the veins.
WARNING: To view vein location most accurately, you
must position the AV500 directly over the center of the vein
being assessed.
WARNING:Vein projection width is most accurate when
the AV500 is positioned closest to the body.
CAUTION:The AV500 projection may not display veins if
operated under bright light such as bright sunlight
Assess the Vasculature
While the vein display light is on, shine the AV500 over the
patient’s skin. You can do this before palpation, scanning
quickly over the skin to help narrow down possible locations,
or after palpation has conrmed vein location and suitability.
You can then often see veins better by rotating the AV500
slightly on its axis and moving the device closer to or further
away from the skin.
Conrm the Vein
After assessing the patient’s vasculature, conrm the site for
your procedure by verifying the location and suitability of the
vein using normal medical techniques and good medical
judgment, such as vein visualization, palpation, and other
medical techniques.
An AccuVein hands-free accessory allows you to keep your
hands free to perform medical procedures.You can also hand
the AV500 to an assistant during the procedure.The AV500
should be used only by qualied medical professionals and
only in conjunction with appropriate visual and tactile vein
assessment techniques.
7

Charging, cleaning, and disposal
Verify the charging cradle is properly connected (see the
Setup section). Place the AV500 in the charging cradle with
the LCD facing outward to begin charging. A battery charge
iconwilldisplaywhenthe AV500 is charging.Thelightonthe
charging cradle will only turn on when a device is detected.
If the light turns on when there is no device placed in the
charging cradle please call AccuVein support for assistance.
Charging the AV500
The AV500 requires no periodic maintenance, eld calibration,
and is not eld repairable.
To ensure the battery remains charged and ready for use,
you can store the AV500 in its charging cradle or a powered
AccuVein hands-free accessory. The AV500 battery cannot
be overcharged when approved charging devices are used.
CAUTION: Use only the AccuVein P510 power supply with
the CC500 cradle or other AccuVein approved accessories.
When the AV500 battery gets low the battery indicator will
ash yellow or red and beep repeatedly. Before the battery is
completely depleted, an alert requesting to charge the bat-
tery will be displayed on the screen.The AV500 will resume
normal operation once it has been charged.
In normal operation, the AV500 battery is expected to be
replaced about every two or three years. Battery life depends
on factors such as usage times, temperature of the device,
and number of charging cycles. Longer charge cycles or
shorter operating periods are indications that the battery
should be replaced.
To replacethe battery the devicecanbe returnedto an AccuVein
approved facility approved to perform a battery replacement.
Operate the device in
powered hands-free
stand
80% to 100% charge
60% to 80% charge
40% to 60% charge
20% to 40% charge
Inoperable due to
low charge
8

Charging, cleaning, and disposal
Cleaning and Disinfecting
WARNING: Usersshould inspect the AV500 and clean and
disinfect the AV500 as required by their institution’s policies
to ensure that it is suciently clean before each use.
WARNING: Do not use AV500 if the vein illumination
window is scratched or dirty.The AV500 should be returned
toAccuVein for servicing ifthe veinlightwindowisscratched.
For peak performance, the optical surfaces and lenses on the
back of the AV500 should be kept clean. Use alcohol wipes
or any soft lens wipe with several drops of 70% isopropyl
alcohol. Dirt or scratches on the vein display window show
up as dark shadows in the vein projection.
To clean the body of the AV500 and its accessories, you may
use an AccuVein approved cleaner using AccuVein’s and the
manufacturer’s instructions. Below aresomeapprovedcleaners.
For a full list of approved and unapproved cleaning materials
and procedures visit the AccuVein website
www.accuvein.com/clean
PDI Super Sani-Cloth, PDI Sani-Cloth Plus, Pre-moistened
bleach wipes (10% or less), Caviwipes1 or Cavicide1, Cidex
Plus, T-Spray II, Birex, Incides N, Incidin Plus, Incidin Pro,
EcoLab SaniCloth Active
Do not immerse theAV500, theAV500 charging cradle,orthe
AV500 hands-freeaccessoriesin liquid orget the AV500or its
components wet such that liquid spills o. Do not attempt to
sterilizethe AV500withheatorpressure sterilizationmethods.
Do not clean theAV500 whilein a chargingcradle or hands-
free accessory.
Do not clean the AV500 when the battery cover is removed.
Unplug the charging cradle before cleaning the cradle.
Disposal
As required by the WEEE (Waste Electrical and Electronic
Equipment Directive) of the European Community and other
national laws, AccuVein oers all end users the possibility to
return“end of life”units without incurring disposal charges.
• The oer is valid for AccuVein electrical and electronic
equipment
• The unit needs to be complete, not disassembled and
not contaminated.
If you wish to return an AccuVein product for waste recovery
please contact AccuVein customer service.
Waste Treatment is Your Responsibility
If you do not return an“end of life”unit to AccuVein you must
hand it to a company specialized in waste recovery. Do not
disposeof a unit in alitterbinor ata public wastedisposalsite.
Itis wellknownthatcertain materialspollutetheenvironment
by releasing toxic product during decomposition.The aim of
theRoHS directiveistoreducethe contentoftoxicsubstance in
electronic products in the future. AccuVein’s business practice
is for each product to meet the RoHS directive.
The intent of theWEEE directive is to enforce the recycling of
electrical/electronic waste. By controlling recycling of end of
life products AccuVein seeks to avoid the negative impacts
of its products on the environment.
9

Accessories
The AV500VeinVisualization System includes an AV500 vein
illuminator with integrated rechargeable battery, a charging
cradle, power supply, and instructional documents.
AccuVein oers optional hands-freestands that many practitio-
nersnd useful.Forinformationabout these and other optional
accessories visit the AccuVein website www.accuvein.com.
HF510
Unpowered hands-free arm with
clamp
HF550
Unpowered wheeled hands-free arm
HF570
Powered wheeled hands-free arm
10

Troubleshooting and service
Service
If the AV500 detects that it cannot operate properly, it turns
o the vein display light and displays an alert or fault screen.
When the AV500 is not operating properly turn the device
o using the side purple power on/o button.
Alerts appear if you operate the device in an environment
that is too cold (less than 4°C/39°F) or too hot (more than
33°C/90°F). Should a temperature alert occur, simply bring
the AV500 back within its operating temperature range.
If the fault screen appears, you should stop using the AV500
immediately.Turnothe deviceandcontactAccuVein Customer
support.They may ask for the serial number and fault code
that appears on the fault screen.
Forall customer service needs inside the USA, contact AccuVein
customer support via telephone at [phone]. For cus-
tomerinquiriesoutsidethe UnitedStates, please contact your
local approved distributor or send an email to international-
[e-mail].
Faults & Alerts
The AV500 will alert the user if it is not able to operate.
Fault
Unit faulted. Contact AccuVein Customer
Support.
For all service needs inside the USA,
contact AccuVein customer support
via telephone at [phone]. For
customer inquiries outside the United
States, please contact your local
approved distributor or send an email to
international-serv[email protected].
Too Cold Alert
Unit too cold. Bring the device above
4°C/39°F
Too Hot Alert
Unit too hot. Bring the device below
33°C/90°F
Charging Issues
• Check that the device is plugged into an approved
AccuVein charging accessory.
•
If the light on the charging cradle does not turn on, the
problem lies within the charging accessories.
11

EMI/EMC
Guidance and Manufacturer’s Declaration—Electromagnetic Immunity
The AV500 is intended for use in the electromagnetic environment specied below. The customer or the user of the AV500 should assure that it is used in such an environment.
Immunity Test IEC 60601 test level Compliance level Electromagnetic environment – guidance
Electrostatic discharge (ESD) IEC
61000-4-2 ±6kV Contact
±8kV Air
±6kV Contact
±8kV Air
Floors should be wood, concrete, or ceramic tile. If oors are covered with synthetic
material, the relative humidity should be at least 30 %.
Electrical fast transient/burst IEC
61000-4-4 ±2kV for power supply lines
±1kV for input/output
lines
±2kV for power supply
Lines
±1kV for input/output
lines
Mains power quality should be that of a typical commercial or hospital environment.
Surge
IEC61000-4-5
±1kV line(s) to line(s)
±2kV line(s) to earth
±1kV line(s) to line(s)
±2kV line(s) to earth
Mains power quality should be that of a typical commercial or hospital environment.
Voltage dips, short interruptions
and voltage variations on power
supply input lines
IEC61000-4-11
<5% UT >95% dip for
0.5 cycle
40% UT 60% dips
70% UT 30% dip
Mains power quality should be that of a typical commercial or hospital environment. If
the user of the AV500 requires continued operation during power mains interruptions, it
is recommended that the AV500 be powered from an uninterruptible power supply or a
battery.
Power frequency (50/60 Hz)
magnetic eld
IEC61000-4-8
3 A/m 3 A/m Power frequency magnetic elds should be at levels characteristic of a typical location in a
typical commercial or hospital environment.
NOTE: UT is the a.c. mains voltage prior to application of the test level.
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The AV500 is intended for use in the electromagnetic environment specied below. The customer or the user of the AV500 should assure that it is used in such an environment.
Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to 80 MHz
3 Vrms Portable and mobile RF communications equipment should be used no closer to any part of the AV500,
including cables, than the recommended separation distance calculated from the equation applicable to the
frequency of the transmitter. Recommended separation distance
where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation distance in meters (m). Field strengths from xed RF
transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each
frequency range. Interference may occur in the vicinity of equipment marked with the following symbol:
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2.5 GHz
3 V/m
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 aected by absorption and reection from structures, objects, and people.
Field strengths from xed 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 xed RF transmitters, an electromagnetic site survey should be
considered. If the measured eld strength in the location in which the AV500 is used exceeds the applicable RF compliance level above the AV500 should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the AV500. Over the frequency range 150 kHz to 80 MHz,
eld strengths should be less than 3 V/m.
12

Running head
Guidance and Manufacturer’s Declaration—Electromagnetic Emissions
The AV500 is intended for use in the electromagnetic environment specied below. The customer or the user of the AV500 should assure that it is used in such an environment.
Emissions Test Compliance Electromagnetic Environment Guidance
RF Emissions
CISPR 11
Group 1 The AV500 uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any
interference in nearby electronics.
RF Emissions
CISPR 11
Class A The AV500 is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage
power supply network that supplies buildings used for domestic purposes.
Harmonic Emissions
IEC 6100-3-2
Complies
Voltage Fluctuations
IEC 6100-3-3
Complies
Recommended separation distances between portable and mobile RF communications equipment and the AV500
The AV500 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the AV500 can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the AV500 as recommended
below, according to the maximum output power of the communications equipment.
Rated Maximum Output power of
transmitter, W Separation distance according to frequency of transmitter, m
150kHz to 80MHz
D = 1.2P
80MHz to 800MHz 800MHz to 2.5GHz
0.01 0.12 0.12 0.12
0.1 0.38 0.38 0.38
11.2 1.2 1.2
10 3.8 3.8 3.8
100 12 12 12
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated 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 separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is aected by absorption and reection from structures, objects, and people.
EMI/EMC
13

Product labels
Laser classication
Vein illuminator exit window
Vein imaging entrance window
Manufacturer
Unique Device Identier
Laser wavelength
Laser energy level
Date of manufacture
Serial number
14

Product specications
Description
Weight 275 grams (9.7 oz.)
Size 5 x 6 x 20 cm (2" x 2.4"
x 7.9")
Integrated Battery, BA500 Product contains
integrated Li-Ion battery.
3.6V, 3,100 mAh
Continuous (vein light on) run time on
full charge:
Typically, 120 minutes
Maximum charging time Charging battery from 5%
charged to 100%
3 hours 45 minutes
CC500 desktop charging cradle + PS510
power supply
5V 2.0A
100V-240V 50Hz-60Hz
0.4A
Product sealing Dust / liquid IPx0
Environment
Operating Temperature 4°C to 33°C (39°F to 90°F)
Humidity 5% to 85% RH non-
condensing
Pressure 75kPa to 106kPa
Transport Temperature -20°C to 50°C (-4°F to
122°F)
Humidity 5% to 85% RH non-
condensing
Storage Temperature -20°C to 50°C (-4°F to
122°F)
Humidity 5% to 85% RH non-
condensing
15

745-00001B
AccuVein Inc.
3243 Route 112
Bldg. 1 Ste 2
Medford, NY 11763
www.accuvein.com
Phone: [phone]