Operating Guide ACU0001969_A
Contents
1. Press the blue side button for 2 seconds or press the Power button beneath the LCD screen on the right User Programmable Name Battery Status Status Information Button Legends AV300 OPERATING GUIDE Status Information Viewing Right Button Middle Button Left Button Vein Display Setting 7 Operating the AV300 ni lt 66 AccuVein recommends that the AV300 only be operated when its battery is charged to 16 or greater of full charge indicated by a bar with in the battery icon or when the device is op erated in a powered hands free stand Greater than 35 charge level is indicated when the battery icon at the upper right of the LCD screen shows a green bar Positioning the AV300 WARNING The AV300 enables location of certain peripheral veins and is not a substitute for sound medical judgment based on the visual and tactile location and assessment of veins The AV300 should be used only as a supplement to the judgment of a qualified professional 3 4 AV300 OPERATING GUIDE WARNING Io view vein location accurately you must position the AV300 at the proper height and angle and directly over the center of the vein being assessed The User Manual has additional detail on proper positioning of the AV300 Hold the device approximate ly 7 inches 180 mm over the surface of the skin and at a right angle perpendicular to the direction of the veins Also make sure the v2. 997 9400 Cold Spring Harbor NY 11724 www accuvein com og Ge 0003691A
3. a physician or other qualified medical professional CAUTION For external use only iv AV300 OPERATING GUIDE A Equipment Care Warnings WARNING Do not immerse the AV300 the AV300 charging cradle or the AV300 hands free stand in liquid or get the AV300 or its components so wet that liquid spills off WARNING Do not attempt to sterilize the AV300 with heat or pres sure sterilization methods WARNING The AV300 will not display veins if operated outside its temperature range WARNING Electromagnetic Interference EMI can affect the proper performance of the device Normal operation can be restored by removing the source of the interference WARNING Do not attempt to open disassemble or service the bat tery pack Do not crush puncture short external contacts or dispose of in fire or water Do not expose to temperature above 60 C 1409F WARNING To 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 moisture WARNING Use only AccuVein accessories and replacement parts with the AV300 The use of non AccuVein accessories may degrade safety WARNING The USB port under the battery cover should never be used in a patient environment A Equipment Care Cautions CAUTION Use only AccuVein approved battery charging accessories AccuVein BA300 batteries and AccuVein brand powered stand If the AV300 will not be used
4. for an extended time remove and store battery in a safe dust free location CAUTION Dispose of used batteries according to manufacturer s instructions A lithium ion battery that is recyclable powers the AV300 Please call AccuVein at 816 997 9400 for information on how to dispose or recycle this battery CAUTION Do not disassemble The AV300 contains no customer serviceable components The AV300 and its accessories should be serviced only by an authorized AccuVein repair department Should the vein display light need to be turned off immedi ately press and hold the blue side button for at least one half second The AV300 battery should only be charged using an AccuVein battery charger and replaced as instructed in this manual only with an approved AccuVein battery If the AV300 is not going to be used for an extended period of time the battery should be removed for storage Removing or replacing the battery BA300 is not to be done in the patient environment A qualified medical professional may locate certain peripheral veins and may observe the center of those veins using the AV300 Depend ing on the distance the AV300 is held from the skin the displayed vein might be slightly wider or narrower than the actual vein Also if the AV300 is not held directly over the vein the vein may be displayed offset from its true position For accurate vein presentation the AV300 should be held at the height angle and centered po
5. operate and the device cannot be used When the AV300 is charging the animated battery charge icon will display If the device is being used where there is no reliable source of elec tricity additional batteries can be charged using the optional stand alone battery charger and used as replacements as necessary In normal operation the AV300 battery needs to be replaced about every two years Longer charge cycles shorter operating periods and the bad battery alert are all indications that the battery should be replaced To replace the battery open the battery compartment on the nar row end of the device s underside Use a screwdriver or edge of a small coin Be careful not to touch or scratch the lenses on the back 5 AV300 OPERATING GUIDE of the device You can check a battery s charge while it s not in the device by inserting a pen or paper clip into the small hole in the battery An indicator light will illuminate if the battery is sufficiently charged for at least 30 minutes of normal operation 9 Cleaning and Disinfecting WARNING Users should inspect the AV300 and clean and disinfect the AV300 as required by their institution s policies to ensure that it is sufficiently clean before each use WARNING Do not use AV300 if the vein display light window is scratched or dirty The AV300 should be returned to AccuVein for servicing if the vein light window is scratched To clean the body of the AV300 and its chargi
6. 4 F to 122 F 5 to 85 RH non condensing 20 C to 50 C 4 F to 122 F 5 to 85 RH non condensing Standards IEC 60601 1 Medical Electrical Equipment Safety IEC 60601 1 2 Electromagnetic Immunity IEC EN 60825 1 Safety of Laser Products Complies with 21 CFR 1040 10 and 1040 11 except for deviations pursuant to Laser Notice No 50 dated June 24 2007 UL 60601 1 Medical Electrical Equipment Safety CAN CSA C22 2 No 601 1 M90 Medical Electrical Equipment Safety AV300 OPERATING GUIDE Product Labels Product and Serial Number Label Laser Safety Label with Laser Classification Notice Location Bottom of battery compartment Location Outer face of battery compartment door A Complies with 21 CFR AccuVein LLC Manufactured In ee Rx ON LY FOR EXTERNAL USE 1040 10 and 1040 11 ex ml 40 Goose Hill Rd for AccuVein LL E ONLY C cept for deviations pursu Gold Spring Hrbr NY onforms to UL Std 60601 1 Cert to ant to Laser Notice No AV300 US 3 7 VZ 2400mAh BA300 battery CAN CSA Std C22 2 No 601 1 M90 50 dated June 24 2007 AV300 Rev 1 0 in Rx AS Manufactured AV300B012 0003687A Ee Information Label with Laser Product Notice Location Inner face of battery compartment door EMERGO EUROPE Molenstraat 15 18 2513 BH The Hague The Netherlands Phone 31 70 345 8570 Fax 31 70 346 7299 0001980A 9 AccuVein AccuVein LLC 40 Goose Hill Road Phone 816
7. English Francais Deutsch Espanol Italiano AccuVein NO Operating Guide A health professional s guide for basic use and operation AV300 OPERATING GUIDE AV300 Operating Guide A practitioner s guide for basic use and operation AV300 Operating Guide AccuVein LLC 2009 AccuVein LLC 40 Goose Hill Road Cold Spring Harbor NY 11724 Phone 816 997 9400 www accuvein com og AV300 is manufactured for EMERGO EUROPE AccuVein LLC EC REP Molenstraat 15 40 Goose Hill Road 2513 BH The Hague Cold Spring Harbor NY 11724 The Netherlands Phone 31 70 345 8570 Fax 31 70 346 7299 Device fully complies with European Directive 2002 364 EC Conformit Europ enne CE 0086 IEC EN 60825 1 Safety of Laser Products Complies with 21 CFR 1040 10 and 1040 11 except for deviations pursuant to Laser Notice No 50 dated June 24 2007 Shown at Right Laser Classification Notice Shown at Right Laser Product Notice AccuVein AV300 is the registered trademark of AccuVein LLC The content of this manual including all photographs and drawings is the proprietary in formation of AccuVein LLC This manual last revised June 26 2009 Warnings and Cautions A Read all instructions cautions and warnings prior to use This product should be operated only by qualified medical professionals The AV300 should not be used as the sole vein location method and it is not a substitute for sou
8. arranty coverage Contact AccuVein see the AV300 User Manual or see www accuvein com legal warranty for full details of warranty coverage AV300 OPERATING GUIDE 12 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 limitation lost profits or lost business opportu nity 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 possibil ity of such damages The foregoing limitation shall apply regardless of the form of the claim in which such liability may be asserted in cluding breach of contract tort including negligence or otherwise 7 AV300 OPERATING GUIDE 13 Specifications General Weight Size Battery Continuous vein light on run time on full charge Number of standard viewing procedures that can be performed using a fully charged battery Charge time full Operating Temperature Humidity Transport Temperature Humidity Storage Temperature Humidity 275 grams 9 7 02 5x6x20cm 2 x2 4 x79 AccuVein BA300 user replaceable Li lon 3 7V 2 400 mAh Typically 2 hours 360 Typically 2 hours 4 C to 40 C 39 F to 104 F 5 to 85 RH non condensing 20 C to 50 C
9. ds fully charging the AV300 before first use NOTE Remove the plastic protective cover from the LCD before use WARNING Inspect power cords and supplies for damage If any damage is found do not use until replacement is obtained AV300 OPERATING GUIDE CAUTION Use only the AccuVein PS310 power supply with the C300 cradle and the HF300 powered hands free stand AccuVein also offers optional hands free stands that many practitio ners find useful as well as carrying cases and mobile solutions for practitioners who travel For information about these and other op tional accessories visit the AccuVein web site To ensure the battery remains charged and ready for use store the AV300 in its charging cradle or the HF300 powered hands free stand Follow the instructions that came in the HF300 kit box when using the HF300 The CC300 charging cradle is not to be used in the patient environ ment 3 Intended Use The AccuVein AV300 is a portable hand held instrument that helps qualified medical professionals to locate certain peripheral veins The AV300 is intended to be used only by qualified medical person nel and as a supplement to appropriate medical training and ex perience The AV300 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 and assessment of veins When used properly the AV300 enables users to locate certain pe rioh
10. ein display light is centered directly above the vein s center line Don t move or rotate the device to either side of the vein or this will offset the projected vein from its true location beneath the skin You can then often enhance display quality by adjusting the height and angle slightly In particular moving the device closer or further from the skin can help bring additional veins into view depending on the pa tient s vasculature room lighting and depth of the veins The User Manual has additional detail on proper positioning of the AV300 Using the Practice Card To test the AV300 before using it on a patient use the practice card provided with the device Place the white side of the card face up Turn on the AV300 and its vein display light by pressing the blue side button Hold the AV300 centered over the square about 7 inches 180 mm from the bottom of the AV300 to the surface of the card so the vein display light fits within the red corner marks Adjust the height of the AV300 so the light fills the square When you hold the device properly a vein should appear on the practice card that connects with the vein drawn on either sides of the display field Try rotating the AV300 and you ll notice that the simulated vein starts to disappear as you get further out of line with it Return the device to an approximate right angle with the vein to return the vein to view You can try the AV300 on the back of your ha
11. eral veins in connection with medical procedures such as veni puncture The AV300 can be used whenever vein location is appropriate 1 2 AV300 OPERATING GUIDE Product Description The AV300 operates by using infrared light to detect veins beneath the skin then illuminating the position of the veins on the skin sur face directly above the veins Qualified medical personnel can ob serve the vasculature as displayed to assist them in finding a vein of the right size and position for venipuncture The AV300 only shows peripheral veins 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 AV300 accurately locates the cen ter of a vein Increasing the displacement from directly overhead re sults in an offset in the displayed vein position WARNING AV300 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 The AV300 is not intended to be used as the sole method for lo cating veins and should be used onl
12. ible loca tions or after palpation has confirmed vein location and suitability Be sure to position the AV300 at the proper height angle and cen tering as described above You can then often see veins better by rotating the AV300 slightly on its axis moving the device closer to or further away from the skin and lightly tapping the blue side but ton to cycle through vein display settings You can also select a set ting using the LCD display 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 medical judgment such as vein visualization palpation and other medical techniques AV300 OPERATING GUIDE If performing venipuncture If you re performing venipuncture hand the AV300 to an assistant to hold so both of your hands remain free to perform the proce dure You can also use the AV300 in an optional hands free stand available at the AccuVein Web site The AV300 should be used only by qualified medical professionals and only in conjunction with ap propriate visual and tactile vein assessment techniques 8 Charging the AV300 When the AV300 battery gets low the bat tery indicator flashes yellow or red you should charge the battery by placing the device in its charging cradle with the LCD screen facing outward While the AV300 is in its charging cradle the vein display light does not
13. nd medical judgment and the visual and tactile location of veins Before using the AV300 on a patient qualified medical professionals must read and understand this AV300 Operating Guide and the AV300 User s Manual which may be found on the DVD provided with the de vice Qualified medical professionals contemplating use of the AV300 also should become familiar with how to properly position the device by following the instructions below Before first use users should compare how the AV300 detects veins with visual detection and palpation techniques All vein location using the AV300 should be confirmed with appropriate medical judgment based on visual and tactile vein location and assessment techniques A Patient and User Safety Warnings WARNING The AV300 enables location of certain peripheral veins and is not a substitute for sound medical judgment based on the visual and tactile location and assessment of veins The AV300 should be used only as a supplement to the judgment of a qualified professional WARNING The AV300 should only be operated when its battery is sufficiently charged indicated when the battery icon at the upper right of the LCD screen has a bar inside battery outline or when the device is operated in a powered hands free stand to ensure AV300 is available for use WARNING The AV300 displays only peripheral veins and does so only to limited depths dependent on a variety of patient factors The AV300 does not i
14. nd or on your arm to get a feel for how this works Basic Steps to Remember Press the blue side button Press the blue side button to power on the AV300 and turn on the vein display light While the light is on quickly tap the blue side button to cycle through various vein display settings and select the one that works best for your patient and pro cedure To turn the vein display light off press the blue side button for one half second This leaves the device on so you can use the LCD screen Press the blue side button again to turn the vein display light back on and begin locating veins again To power off both the light and the AV300 press the blue side button for two seconds WARNING Do not shine vein display light in eyes CAUTION 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 capa ble of blocking 642 nm and 785 nm should be used A commercially available laser safe eye shield that s suitable for eye protection is the Laser Aid Eye Shield Glendale and Laser Aid are trademarks of their respective owners Assess The Vasculature While the vein display light is on shine the AV300 over the patient s skin You can do this before palpation scanning quickly over the skin to help narrow down poss
15. ndicate vein depth WARNING Do not shine vein display light in eyes WARNING Do not hold the AV300 while performing venipuncture or other medical procedures WARNING Keep the AV300 and its battery out of the reach of children WARNING AV300 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 AV300 OPERATING GUIDE iii WARNING To view vein location accurately you must position the AV300 at the proper height and angle and directly over the center of the vein being assessed A Patient and User Safety Cautions CAUTION 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 A commer cially available laser safe eye shield that s suitable for eye protection is the Glendale Laser Aid Eye Shield Glendale and Laser Aid are trademarks of their respective owners CAUTION Operation or use of the AV300 in a manner different than specified in this AV300 Operating Guide and the AV300 User s Manual may result in hazardous radiation exposure CAUTION Federal law restricts this device to sale by or on the order of
16. ng cradle use a cloth moistened with soap and water 70 isopropyl alcohol a 10 dilu tion of chlorine bleach in distilled water or chlorhexidine You can also use normal household disinfectants and wipes Do not immerse the AV300 the AV300 charging cradle or the AV300 hands free stand in liquid or get the AV300 or its compo nents so wet that liquid spills off Do not scratch the vein display light window clean only as di rected Do not attempt to sterilize the AV300 with heat or pressure steril ization methods Do not clean the AV300 while in a charging cradle or hands free stand Do not clean the AV300 when the battery door is open or re moved Unplug the charging cradle before cleaning the cradle For peak performance the optical surfaces on the bottom of the AV300 and the lenses on the back of the device should be kept clean as well Use only a 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 10 Troubleshooting If the AV300 detects that it cannot operate properly it turns off the vein display light and displays an alert or fault screen Alerts appear if you operate the device in an environment that s too cold less than 5 C 41 F or too hot more than 40 C 104 F Should a temperature alert occur simply bring the AV300 back within its operating temperature range Other alerts indicate when the bat
17. sition described in this AV300 Operating Guide and the AV300 User Manual available on the AV300 DVD 10 11 12 13 ar fa I d ie gt About This Guide Setup Intended Use Product Description Contraindications User Controls and Screens Operating the AV300 Charging the AV300 Cleaning and Disinfecting Troubleshooting Warranty Summary Limitation of Liability Specifications AV300 OPERATING GUIDE v I About This Guide This operating guide provides an overview of how to operate the AV300 Additional details including recommended techniques instruc tions on using advanced features of the AV300 and optional accesso ries can be found in the AV300 User Manual on the DVD that accompanies the AV300 The AV300 User Manual can also be downloaded from www accuvein com og NOTE The photographs in this AV300 Operating Guide may show prototype products The available device and accessories may incorporate changes AC cuVein reserves the right to discontinue or modify products and accessories 2 The AV300 Vein Viewing System includes an AV300 vein viewer with rechargeable battery a charging cradle and power supply docu ments including a practice card an instructional DVD and other ac cessories The first time the AV300 is turned on the language needs to be selected default is English For more information on setting device language see User Manual on the supplied DVD Setup NOTE AccuVein recommen
18. tery needs to be charged or replaced If the Fault screen appears you should stop using the AV300 im mediately Turn off the device by pressing the right circular Power button under the LCD screen Otherwise the device will automati cally turn off in 30 seconds Then contact AccuVein support via tele phone at 816 997 9400 11 Warranty Summary AccuVein warrants the AV300 when purchased new from an autho rized seller 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 war ranties within this time limit at no cost to the customer You must obtain an RMA number from AccuVein technical support Contact AccuVein support at 816 997 9400 for service or additional infor mation These warranties do not cover any misuse or abuse These warran ties are also void if the instrument is repaired by other than Accu Vein or an authorized agent There are no other warranties either express or implied other than those set forth in AccuVein s written warranty AccuVein has an optional Premium warranty service agreement that extends warranty coverage of the AV300 to 3 years This is only a summary of the AccuVein w
19. y by a qualified medical pro fessional who should do so either prior to palpation to help iden tify the location of a vein or afterwards to confirm or refute the perceived location of a vein When using the AV300 practitioners should always follow the appropriate medical protocols and prac tices as required by their medical facility as well as exercising sound medical judgment The AV300 requires no routine or preventative maintenance The AV300 is portable internally powered by battery and approved for continuous operation The AV300 is considered a Type B applied part and is not protected by ingress of water 5 Contraindications The AV300 should not be used to locate veins in or near eyes The AV300 is not intended to be used as a diagnostic device or for treatment of any kind 6 User Controls and Screens Blue Side Button Battery armen In Rear AV300 Controls at a glance Power AV300 ON Turn vein display light ON or OFF Cycle through vein display settings Power AV300 OFF LCD Screen Left Center amp Right Buttons Note To turn OFF the vein display light at any time press the right on off button if active or press and hold N the blue side button Press the blue side button or the Power button beneath the LCD screen on the right While the AV300 is powered ON press the blue side button for Y2 one half second While the vein display light is ON lightly tap the blue side button
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