AccuVein AV400 User Manual
Contents
1. device below 33 C 90 F Selected time out Less than 2 minutes of battery charge remaining Charge battery immediately Gum AV130112345 1000 1 0 00 1 0 00 0 About product Unit faulted Call AccuVein Support at 816 997 9400 Basic Use and Operation Operating the AV400 Positioning the AV400 Power on off button P Press the on off button to power on or off the AV400 Blue button The blue button is located on the left side of the AV400 Press the blue button to power on the AV400 and turn on the vein display light Press the button again to turn the vein display light off This leaves the device on so you can navigate the de vice settings Press the blue side button again to turn the vein display light back on and begin locating veins again Hold the device from 4 18 10 to 45 cm over the surface of the skin Scan the area of interest to view Once a vein is selected make sure the vein display light is centered direct ly above the vein s center line Don t move or tilt the device to either side of the vein or this will offset the projected vein WE time out setting from its true location beneath the skin You can then often en hance display quality by slightly adjusting the height and an gle to the skin In particular moving the device closer or fur ther from the skin can help bring additional veins into view depending on the pati2. EMERSO EUROPE Ae behind battery cover Peak Power 26 mi 1 25 mW EC Moenstraa 15 k RRI e Mon Pulse Energy 270 nJ 270 nJ 2313 BH The Hague The Netredands Pulse Length 11 ps Benne 31 7H ME 2STO IEC EN 60825 1 2001 07 Fax 14 70 SR TCO yr Laser Safety Label with Laser Classification Notice TENA N VISIBLE ANO Ni Accu er n In c y x AA INVISIBLE m 3 Ty LASER R A RADIATION GTa gt ee Z SER q DO NOT STARE INTO on y BEAM CLASS 2 No Laser procuct IE AV400 EX AV12401234 Ee ACU0004962
3. English Y AccuVein AccuVein AV400 User Manual A health professional s guide for use and operation of the AccuVein AV400 This AV400 User Manual and additional information can also be downloaded from www accuvein com AV400 User Manual AV400 is manufactured for AccuVein Inc 2012 AccuVein Inc AccuVein Inc 40 Goose Hill Road 40 Goose Hill Road Phone 816 997 9400 Cold Spring Harbor NY 11724 United States of America Cold Spring Harbor NY 11724 United States of America www accuvein com EMERGO EUROPE ec REP Molenstraat 15 2513 BH The Hague The Netherlands Phone 31 70 345 8570 Fax 31 70 346 7299 VISIBLE AND INVISIBLE Wavelength 642 nm 785 nm LASER RADIATION Peak Power 25 mW 25 mW DO NOT STARE Pulse Energy 270 nJ 270n INTO BEAM CLASS 2 LASER Pulse Length 11 us PRODUCT IEC EN 60825 1 2001 07 Device fully complies with For United States of America customers European Directive 2002 364 IEC EN 60825 1 Safety of Laser Product EC Conformit Europ enne Complies with 21 CFR 1040 10 and 1040 11 except for deviations pursuant to Laser Notice No 50 dated June 24 2007 0086 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 October 2012 Warnings and Cautions Read all instructions cautions and warnings prior to use This produ
4. RNING Users should inspect the AV400 and clean and disinfect the AV400 as required by their institution s policies to ensure that it is sufficient ly clean before each use WARNING Do not use AV400 if the vein illumination window is scratched or dirty The AV400 should be returned to AccuVein for servicing if the vein light window is scratched For peak performance the optical surfaces and lenses on the back of the AV400 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 AV400 and its charging cradle you may use a cloth moistened with 70 isopropyl alcohol a 10 dilution of chlorine bleach in distilled water or soap and water You can also use common household dis infectants and wipes Do not immerse the AV400 the AV400 charging cradle or the AV400 hands free stand in liquid or get the AV400 or its components wet such that liquid spills off Do not attempt to sterilize the AV400 with heat or pressure steril ization methods Do not clean the AV400 while in a charging cradle or hands free accessory Do not clean the AV400 when the battery cover is removed Unplug the charging cradle before cleaning the cradle Troubleshooting Warranty and Liability If the AV400 detects that it cannot operate properly it turns off the vein dis play light and displays a
5. TION United States Federal law restricts this device to sale by or on the order of a physician or other qualified medical professional CAUTION Operation or use of the AV400 in a manner different than specified 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 off WARNING Do not attempt to open disassemble or service the battery pack Do not crush puncture or dispose of the battery in fire 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 lo reduce the risk of fire 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 Ifthe 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 AccuV
6. ary secure a dif ferent power adaptor to the power supply and before plug ging it into an outlet Remove the plastic protective cover from the LCD before use AX WARNING Inspect power cords and supplies for dam age If any damage is found do not use until replacement is obtained AM CAUTION Inspect the power adaptor on the power supply to confirm it is properly secured AccuVein also offers optional hands free stands that many practitioners find useful For information about these and other optional accessories visit the AccuVein web site www accuvein com Intended Use The AccuVein AV400 is a portable hand held instrument that helps medical professionals to locate certain superficial veins The AV400 is intended to be used as a Supplement to appro priate medical training and experience The AV400 should not be used as the sole method for locating veins and should be used only by a qualified medical professional who should do so either prior to palpation to help identity the location of a vein or afterwards to confirm or refute the perceived location of a vein When using the AV400 medical practitioners should always follow the appropriate medical protocols and practic es as required by their medical facility as well as exercising sound medical judgment When used properly the AV400 enables users to locate cer tain superficial veins in connection with medical procedures such as venipuncture The AV400 can be used w
7. ct should be operated only by qualified medical professionals The AV400 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 AV400 on a patient qualified medical professionals must read and understand this AV400 User s Manual Before first use users should compare how the AV400 detects veins with visual detection and palpation techniques English Y AccuVein AV400 AccuVein AV400 User Manual A health professional s guide for use and operation of the AccuVein AV400 Contents English O AccuVein AV400 AccuVein AV400 User Manual A health professional s guide for use and operation of the AccuVein AV400 Y AccuVein Basic Use Charging Cleaning Warranty Product and Operation 6 and Troubleshooting 1 3 and Liability 1 6 Specification 1 Setup Charging the AV400 Warranty Summary Specifications Intended Use Cleaning and Disinfecting Limitation of Liability Product labels Product Description Troubleshooting User controls and screens Operating the AV400 NTERTEZ lb Caution Consult operating instructions Refer to instruction manual booklet The AV400 emits laser radiation Type B Applied Part Conformit Europ enne European Conformity This symbol means that the device fully complies with European Directive 93 42 EEC ETL Classified means that most sy
8. customer Contact AccuVein support at 816 997 9400 option 3 for service or addition al information These warranties do not cover any misuse or abuse These warranties are also void if the instrument is repaired by other than AccuVein or an authorized agent There are no other warranties either express or implied other than those set forth in AccuVein s written warranty This is only a summary of the AccuVein warranty coverage Contact AccuVein or see www accuvein com legal warranty for full details of warranty coverage Limitation of Liability In no event shall either AccuVein or the customer be liable to the other for any incidental indirect special or consequential damages including without lim itation lost profits or lost business opportunity that the other party may incur by reason of its having entered into or relied on a purchase or lease agreement or arising out of the performance or breach of such an agreement even if the party against whom a claim is made was advised or knew of the possibility of such damages The foregoing limitation shall apply regardless of the form of the claim in which such liability may be asserted including breach of contract tort including negligence or otherwise Product Specification Guidance and Manufacturer s Declaration Electromagnetic Immunity Guidance and Manufacturer s Declaration Electromagnetic Emissions The AV400 is intended for use in the electromagnetic environme
9. e a c mains voltage prior to application of the test level Recommended separation distances between portable and mobile RF communications equipment and the AV400 The AV400 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the AV400 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the AV400 as recommended below according to the maximum output power of the communications equipment Rated Maximum Output power of transmitter Separation distance according to frequency of transmitter m 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz IMMUNITY TEST IEC 60601 TEST COMPLIANCE Electromagnetic Environment LEVEL LEVEL Guidance Portable and mobile RF communications equipment should be used no closer to any part of the AV400 including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3 Vrms 3 Vrms d 1 2VP IEC 61000 4 6 150 kHz to 80 MHz d 1 2VP 80 MHz to 800 MHz Radiated RF 3 V m 3 V m IEC 61000 4 3 80 MHz to 2 5 GHz d 2 3VP 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended
10. ein battery Removing or replacing the battery should not to be done in the patient environment CAUTION Electromagnetic Interference EMI can affect 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 will not display veins if operated outside its temperature 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 Do not disassemble or modify the AV400 or any of its charging accessories 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 Basic Use and Operation Setup The AV400 Vein Viewing System includes an AV400 vein illu minator with rechargeable battery a charging cradle pow er supply and power adaptors and instructional documents AccuVein recommends fully charging the AV400 before first use Connect the charging cradle to the power supply The AV400 comes with power supply country adaptors to ensure outlet compatibility in your country If necess
11. ent s vasculature room lighting and depth of the veins A WARNING To view vein location accurately you must position the AV400 directly over the center of the vein being assessed AN CAUTION The AV400 projection may not display veins if op erated under bright light such as bright sunlight The time out setting determines the amount of time until the vein display light turns off This setting may help increase bat tery operation time of the AV400 To set the time press the left button to go into the time out menu The time out can be set to 0 no time out 2 minutes 5 minutes or 15 minutes 13 Basic Use and Operation Operating the AV400 continued a Inverse setting 14 The inverse setting inverts the dark shadow and light red projection areas of the AV400 such that the veins can be de picted by either light or dark Changing the inverse setting may improve vein visibility and eye comfort level AccuVein recommends reversing the vein display to show light veins in cases where veins are very small When operating the device outdoors or in bright surroundings use the dark veins settings to enhance visibility A WARNING Do not shine vein display light in eyes A WARNING Blink reflexes can be inhibited or reduced by disease drugs or other medical conditions For patients who might have inhibited or reduced bright light blink reflexes Ac cuVein recommends outfitting the patient with a protective eye s
12. he AV400 requires no routine or preventative maintenance The AV400 is portable internally powered by battery and ap proved for continuous operation The AV400 is considered a Type B applied part and is not protected by ingress of water The technology in the AV400 is covered by the following pat ents US 8 073 531 US 7 904 138 US 8 150 500 US 7 983 728 Mexico 0357588 Other US and international patents pending Visit www accuvein com for the most current information Basic Use and Operation User controls and screens Lens LCD Screen Vein Illumination Window Lens Keypad Battery Compartment Door Blue Button Left Button Center Button Power Button Basic Use and Operation AV400 controls at a glance Power AV400 ON or OFF amp Turn vein display light ON or OFF Invert the projection About Product Select time out u e OE Display indications Battery charge status O Do not shine in eyes Next selection 4 J A Select item Device in powered hands free accessory 11 12 Basic Use and Operation Operating screen display Projection off ready for use Non operating screen display E LO Projection on dark veins over illuminated background Unit too cold Bring the device above 4 C 39 F Projection on illuminated veins over dark background Unit too hot Bring the
13. henever the determination of vein location is appropriate The AV400 operates by using infrared light to detect veins be neath the skin then projecting the position of the veins on the skin surface directly above the veins Qualified medical per sonnel can observe the vasculature as displayed to assist them in finding a vein of the right size and position for venipuncture and other medical procedures requiring the location of super ficial veins No training is required to operate the AV400 The AV400 only shows superficial 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 high ly contoured skin surface and adipose fatty tissue Basic Use and Operation Product Description When held directly overhead the AV400 accurately locates the center of a vein Increasing the displacement from direct ly overhead results in an offset in the displayed vein position Width of displayed vein may differ trom the actual width de pending on patient to patient differences 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 T
14. hield A protective eye shield capable of blocking 642 nm and 785 nm should be used a Assess the Vasculature While the vein display light is on shine the AV400 over the pa tient s skin You can do this before palpation scanning quickly over the skin to help narrow down possible locations or after palpation has confirmed vein location and suitability You can then often see veins better by rotating the AV400 slightly on its axis and moving the device closer to or further away from the skin Confirm the Vein After assessing the patient s vasculature confirm the site for your procedure by verifying the location and suitability of the vein using normal medical techniques and good medi cal judgment such as vein visualization palpation and oth er medical techniques If performing venipuncture If you are performing venipuncture you may use an AccuVein hands free accessory so both your hands remain free to per form the procedure You can also hand the AV400 to an assis tant during the procedure The AV400 should be used only by qualified medical professionals and only in conjunction with appropriate visual and tactile vein assessment techniques Verity the charging cradle is properly connected see the Set up section Place the AV400 in the charging cradle with the LCD facing outward to begin charging While the AV400 is in its charging cradle the vein display light does not operate and the device cannot be
15. n alert or fault screen See Non Operating Display un der User Screens When the AV400 is not operating properly turn the device off using the round Power on off button A yellow header on the screen indicates an alert Alerts appear if you oper ate 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 AV400 back within its operating temperature range Other alerts indicate when the battery needs to be charged or replaced The fault screen has a red header and is picture above If the fault screen ap pears you should stop using the AV400 immediately Turn off the device and contact AccuVein support via telephone at 816 997 9400 option 3 Warranty Summary AccuVein warrants the AV400 when purchased new from an authorized sell er is of sound materials and workmanship and conforms to the manufacturer s specifications for a period of one year from the date of purchase from AccuVein or its authorized distributors or agents The warranty period for accessories is as follows Charging Cradle 1 year Power Supply 1 year Battery 90 days AccuVein will repair or replace any product that does not satisfy these warran ties within this time limit at no cost to the customer You must obtain a Re turn of Material Authorization RMA number from AccuVein support The re paired unit has a 90 day warranty from the date it is received by the
16. nd those directlv connected Harmonic Emissions Complies to the public low voltage power supply network IEC 6100 3 2 that supplies buildings used for domestic Voltage Fluctuations Complies purposes IEC 6100 3 3 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 lt 5 Ur gt 95 dip in Ur for 0 5 cycles 40 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip in Ur for 25 cycles lt 5 Ur gt 95 dip in Ur for5s lt 5 Ur gt 95 dip in Ur for 0 5 cycles 40 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip in Ur for 25 cycles lt 5 Ur gt 95 dip in Ur for5s Mains power quality should be that of a typical commercial or hospital environment If the user of the AV400 requires continued operation during power mains interruptions it is recommended that the AV400 be powered from an uninterruptible power supply or a battery Guidance and Manufacturer s Declaration Electromagnetic Immunity The AV400 is intended for use in the electromagnetic environment specified below The customer or the user of the AV400 should assure that it is used in such an environment Power frequency 50 60 Hz magnetic field IEC 61000 4 8 3 A m 3 A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE Uris th
17. nt specified below The customer or the user of the AV400 should assure that it is used in such an environment The AV400 is intended for use in the electromagnetic environment specified below The customer or the user of the AV400 should assure that it is used in such an environment IMMUNITY test IEC 60601 Compliance level Electromagnetic environment test level guidance Electrostatic 6 kV contact 6 kV contact Floors should be wood concrete or discharge ESD 8 kV air 8 kV air ceramic tile If floors are covered IEC 61000 4 2 with synthetic material the relative humidity should be at least 30 Electrical fast transient burst 2 kV for power supply lines 2 kV for power supply lines Mains power quality should be that of a typical commercial or hospital IEC 61000 4 4 1 kV input output Not applicable environment lines Surge 1 kV line s to 1 kV differential Mains power quality should be that IEC 61000 4 5 line s mode of a typical commercial or hospital 2 kV line s to earth 2 kV common mode environment Emissions Test Compliance Electromagnetic Environment Guidance RF Emissions Group 1 The AV400 uses RF energy only for its internal CISPR 11 function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronics RF Emissions Class A The AV400 is suitable for use in all establishments CISPR 11 other than domestic a
18. retically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the AV400 is used exceeds the applicable RF compliance level above the AV400 should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the AV400 Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 17 Product Specification Specifications Weight 275 grams 9 7 02 Operating Temperature 4 C to 33 C Size 5x6x 20cm 2 x 2 4 x 7 9 39 F to 90 F Battery AccuVein BA400 user Humidity 5 to 85 Ri replaceable Li lon 3 6V non condensing Transport Temperature 20 C to 50 C BA400 3 100 mAh ries Continuous vein light on Typically 180 minutes Humidity 5 to 85 RH run time on full charge non condensing Number of standard viewing 90 procedures that can be performed storage Sc bse one 4 F to 122 F using a fully charged battery Humidity 5 to 85 RH Charge time full Typically 3 hours T Product labels enccuveining RX oa Fe FOR EXTERNAL Le 3 7 V 3100mAh REF AV400 Rev 1 0 e ce sn AV12401234 N RE Information Label with Laser Product Notice 3 Wavelength 642 nm 785 nm
19. separation distance in meters m Field strengths from fixed 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 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 W d 1 2 VP d 1 2VP d 2 3VP 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 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 affected by absorption and reflection from structures objects and people 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 theo
20. 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 reflexes can be inhibited or reduced by disease drugs or other medical conditions For patients who might have inhibited or reduced blink reflexes AccuVein recommends outfitting 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 blue button is pushed WARNING Do not hold the AV400 while performing venipuncture or other medical procedures WARNING For external use only WARNING Keep the AV400 and its battery out of the reach of children WARNING lo 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 Satety 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 CAU
21. stem 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 qualified medical professionals For external use only Direct Current Example 3 7 V indication of battery voltage Warnings and Cautions Patient and User Safety Warnings WARNING The AV400 enables location of certain superficial veins and is nota substitute for sound medical judgment based on the visual and tactile location and assessment of veins The AV400 should be used only as a supplement to the judgment ofa qualified professional WARNING The AV400 should only be operated when its battery is sufficiently 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
22. used An animated battery charge icon will display when the AV400 is charging The light on the charging cradle will only turn on when a device is detected If the light turns on when there is no device placed in the charg ing cradle please call AccuVein support for assistance To ensure the battery remains charged and ready for use store the AV400 in its charging cradle or a powered Accu Vein accessory AN CAUTION Use only the AccuVein PS310 power sup ply with the CC300 cradle and other AccuVein approved accessories Charging Cleaning and Troubleshooting Charging the AV400 ul 20min 10min When the AV400 battery gets low the battery indicator will flash yellow or red and beep repeatedly Before the battery is completely depleted an alert requesting to charge the battery will be displayed on the screen The AV400 will resume nor mal operation once it has been charged In normal operation the AV400 battery needs to be replaced about every two years Longer charge cycles or shorter operat ing periods are indications that the battery should be replaced To replace the battery open the battery compartment on the narrow end of the device s underside Use a screwdriver or edge of a small coin to unscrew the cover Be careful not to touch or scratch the lenses on the back of the device Do NOT use a tool to remove the battery 15 16 Charging Cleaning and Troubleshooting Cleaning and Disinfecting A WA
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