Warnings and Cautions
Patient and User Safety—Warnings
WARNING:The AV400 enables location of certain supercial veins and is not a
substitute for sound medical judgment based on the visual and tactile location and
assessment of veins. The AV400 should be used only as asupplement to the judgment
of a qualied professional.
WARNING:The AV400 should only be operated when its battery is suciently
charged (indicated when the battery icon at the upper right of the LCD screen is
green), or when the device is operated in a powered hands-free accessory to ensure
AV400 is available for use.
WARNING: AV400 vein location is dependent on a variety of patient factors
and may not display veins on patients with deep veins, skin conditions, hair, scarring
or other highly contoured skin surface, and adipose (fatty) tissue.
WARNING: The AV400 displays only superficial veins, and does so only
to limited depths dependent on a variety of patient factors. The AV400 does not
indicate vein depth.
WARNING:The AV400 emits Visible and Invisible laser radiation. Do not stare
into beam. Class 2 laser product.
WARNING:Do not shine vein display light in eyes.
WARNING:Blink reexes can be inhibited or reduced by disease, drugs, or other
medical conditions. For patients who might have inhibited or reduced blink reexes,
AccuVein recommends outtting the patient with a protective eye shield. A protective
eye shield capable of blocking 642 nm and 785 nm should be used in this case.
WARNING: Stop using the AV400 if the red light does not turn on when the
bluebutton ispushed.
WARNING: Do not hold the AV400 while performing venipuncture or other
medicalprocedures.
WARNING:For external use only.
WARNING:Keep the AV400 and its battery out of the reach of children.
WARNING: To view vein location accurately, you must position the AV400 at
the proper height, and directly over the center of the vein being assessed.
Patient and User Safety—Contraindications
WARNING:The AV400 should not be used to locate veins in or near eyes.
WARNING:The AV400 is not intended to be used as a diagnostic device or for
treatment of any kind.
Patient and User Safety—Cautions
CAUTION: United States Federal law restricts this device to sale by or on the order
of a physician or other qualied medical professional.
CAUTION: Operation or use of the AV400 in a manner dierent than specied in this
AV400 User’s Manual may result in hazardous radiation exposure.
CAUTION: Do not make any connections to the USB port on the AV400 device.
Equipment Care— Warnings
WARNING:Do not immerse the AV400 or the AV400 charging cradle in liquid
or wet the AV400 such that liquid spills 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 not expose to temperature above 60°C / 140°F.
WARNING: Do not modify in any way the interior or exterior components of
the AV400.
WARNING:To reduce the risk of re or shock hazard and annoying interference,
use only the recommended accessories and do not expose this equipment to rain or
heavy moisture.
WARNING: Use only AccuVein accessories and replacement parts with the
AV400. The use of non AccuVein accessories may degrade safety.
Equipment Care—Cautions
CAUTION: Use only AccuVein approved battery charging accessories, AccuVein BA300
and BA400 batteries, and AccuVein brand additional accessories. If the AV400 will not
be used for an extended time, remove and store battery in a safe, dust-free location.
The battery should be replaced only with an approved AccuVein battery. Removing
or replacing the battery should not to be done in the patient environment.
CAUTION: Electromagnetic Interference (EMI) can aect the proper performance
of the device. Normal operation can be restored by removing the source of the
interference.
CAUTION: Do not attempt to sterilize the AV400 with heat or pressure sterilization
methods.
CAUTION: The AV400 willnotdisplayveinsifoperatedoutside itstemperature range.
CAUTION: The AV400 may not display veins if operated under bright light such as
bright sunlight.
CAUTION: Dispose of used batteries according to manufacturer’s instructions.
A recyclable lithium ion battery powers the AV400. Please call AccuVein at
(816) 997-9400 for information on how to dispose or recycle this battery.
CAUTION: Donotdisassemble ormodifytheAV400 orany ofits chargingaccessories.
CAUTION: Do not service. The AV400 contains no customer serviceable components.
The AV400 and its accessories should be serviced only by an authorized AccuVein
repair department.
keith@type ownyc.com
917.370. 8219
Production 1Pc after translations
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Caution
Consult operating instructions
Refer to instruction manual/booklet
The AV400 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 Classied means that most system
elements conform to UL Std 60601-1
Product Serial Number
Reference to Catalog Model Number
Universal Product 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
No water ingress protection
US federal law restricts sale of this device only to physicians or
other qualied medical professionals.For external use only.
Direct Current. Example: 3.7 V indication of battery voltage
Rx Only
IPX0
keith@type ownyc.com
917.370. 8219
Production 1Pc after translations
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917.370. 8219
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