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1. TURNING THE DEVICE ON OFF WEARING THE DEVICE USING THE DEVICE CONTROLS amp INDICATORS USING THE DEVICE WITH A REMOTE MONITOR MAINTENANCE amp SUPPORT REPLACING DISPOSABLE HEADBASKET PADS VUETEK HANDLING AND STORAGE CLEANING VEINSITE SPECIFICATIONS VEINSITE STANDARDS VEINSITE AND ACCESSORIES ORDERING INFORMATION SERVICE AND SUPPORT WARRANTY APPENDIX A VueTek Scientific Operator User Manual Introduction The Veinsite from VueTek Scientific is a near infra red NIR vein imager that is worn on the head to improve the viewing of superficial subcutaneous vasculature The device works by contrasting the vasculature from surrounding tissue while providing portable and hands free operation The Veinsite is designed to provide a non diagnostic enhanced visual aid that is used alongside standard visual and tactile methodology Video of the vasculature is viewed by the user in the headset display The headset and display combination facilitates both visualization in the display and an open field of view directly to the subject s anatomy and practitioner s surroundings Safety amp Clinical Warning U S Federal Law restricts this device to the sale by or on the order of AN a licensed physician or other qualified medical professional The Veinsite is for use by a qualified medical professional only Read all Warning and Cautionary Statements and instructions in their entirety before operating the Veinsite Convention2. VTS1000 CASE Carrying Case VTS1000 PAD2pk Replacement Headband Pad Set 2 pk of 10 ea VTS1000 PAD10pk Replacement Headband Pad Set 10 pk of 10 ea VTS1000 OUM Operator s User Manual this document Note This manual is available at www vuetekscientific com and selecting the Manuals button on the menu bar or by calling 1 207 657 6565 Service and Support attempt to repair or use a malfunctioning unit Doing so could result in injury CAUTION The Veinsite and its accessories are not field serviceable Do not and will void the product warranty Customer and Technical Support within the U S and Canada Telephone 207 657 6567 Facsimile 207 657 6569 Warranty VueTek Scientific VueTek warrants that the Equipment conforms to any specifications provided in writing by VueTek to Customer for that Equipment is of sound materials and workmanship is new and unused unless otherwise specified Except as provided in the above paragraph VueTek is not making and the Customer is not relying on any representations or warranties with respect to the Equipment including without limitation any implied warranty or merchantability fitness for a particular use or arising from course of performance course of dealing or usage of trade Standard Warranty 1 Standard Warranty Period The Warranties with respect to any Equipment shall remain in effect for the following period of time after delivery of the Equipment to the Customer t
3. or cloth Install the battery pack by pressing the blue tab on the battery and pivoting the battery into the unit s pocket see Figure 1 below Removal is the reverse of the installation process When installing a battery pack make sure that the blue tab securely locks in place to retain the battery pack Figure 1 Battery Installation Operator s User Manual English Device Controls and Important Features Top Adjustment Knob Contrast control a Power On Off Battery Rear adjustment Figure 2 Parts and Controls Removing Protective Lens Covering The Veinsite is shipped with a protective film covering the front IR lens material and must be removed prior to use Gently peel this covering off and discard The device is now ready to be used Turning the Device On Off Once the charged battery is installed press the blue power button on the right hand side of the unit to turn on the unit Pressing the button again will turn off the unit The unit may be turned on prior to donning the device or once the device is positioned on the user s head If the device sounds three beeps after turning on there is insufficient charge remaining in the battery to continue Change or charge the battery to continue to use the device CAUTION Applying power to the Veinsite activates the infra red IR A illuminators Use normal precautions as listed in the Patient and User Safety section of this manual VueT
4. bright light source needless staring into the LEDs should be avoided Although there are no known increased risks of exposure of infants to near infrared energy at levels emitted by this product needless exposure of the eyes of infants should be avoided and eye patches could be applied if the instrument is to be used to view vessels of the face The Veinsite display does not pose a potential hazard to the eye of the user under intended use and is also exempt in accordance with ANSI RP27 3 and CIE S009 IEC 62471 2006 Use in Oxygen Enriched Environment The Veinsite has been designed and tested to be used in an oxygen enriched environment The power source does not exceed 10 volt amperes nor does the surface temperature of any component exceed 300 C Oils and grease should not be used on this device and the device should be kept clean while in an oxygen enriched environment Do not insert or remove the battery pack or use the charger while in an oxygen enriched environment Move the device to a normal atmosphere before performing any battery handling operations c Operator s User Manual English The charger is not to be used in an oxygen enriched environment and should not be located in any area where a higher level of oxygen may be encountered Setup amp Use of Device Unpacking amp Inspection The Veinsite kit contains everything necessary to get started with enhanced vein viewing Please carefully remove all of the kit co
5. therefore responsible that the system complies with the medical system requirements If in doubt consult your facility s technical service department or your local Vuetek representative Do not operate machinery equipment or vehicles with the Veinsite positioned on the head and do not walk or climb stairs while wearing the Veinsite to avoid a tripping or falling accident The Veinsite headset and battery charger are not safe for use in harsh electromagnetic environments such as those exhibited with MRI equipment A CAUTIONS Do not examine eyes vasculature in the eye or other structures of the eye Do not look or have patients look directly into the illuminator at close range If the user cannot see the displayed image clearly and without strain continued use may cause eye discomfort and fatigue Although no known increased risks of exposure to near infrared energy at levels emitted by this product have been identified exposure to the eyes should be avoided at all times Appropriate patient eye protection is recommended if the instrument is to be used to view vessels near the eyes such as the face or scalp In extremely bright conditions such as would occur in direct sunlight the image s contrast may be reduced If this occurs shading the area to be imaged will improve the overall contrast in the display It is recommended that the Veinsite be used with sanitary head covering such as a bouffant to reduce the chance of c
6. with enhanced contrast Note All icons are shown for display purposes only Contrast Selection The Contrast Control Button Figure 2 will alternate the display between low contrast and high contrast This selection alters the way the image is processed where fine detail may be enhanced or suppressed The user may find that one mode is preferred over the other when factors such as patient age condition skin tone and physiology Such as hair are considered An indicator in the display will show which mode is currently active Auto Shutoff The Veinsite is equipped with a detector that will turn off the device after approximately 10 minutes if no motion of the headset is detected Battery Status The visual indicator appearing in the upper right hand corner of the display will show eight bars when fully charged with each segment of the icon representing approximately 30 minutes of useful battery life remaining If the remaining battery life is insufficient to continue operation the device will sound 3 beeps and turn off The battery must be charged or changed at this point to continue using the device Fault Indicator If an internal fault is detected during use the imaging will be disabled and an icon in the form of an exclamation mark will be shown on the display Contact VueTek or your distributor for further information Operator s User Manual English Using the Device with a Remote Monitor The Veinsite provides a video ou
7. 0 800MHz D 7 E1 Sqrt P 800 MHz to 2 5 GHz where P is the max power in watts and D is the recommended separation distance in meters Field strengths from fixed transmitters as determined by an electromagnetic site survey should be less than the compliance levels V1 and E1 Interference may occur in the vicinity of equipment containing a transmitter VueTek Scientific 22 Shaker Rd Gray Maine 04039 USA 207 657 6565 TEL 207 657 6569 FAX www vuetekscientific com M 10571
8. What is displayed by the Veinsite can be affected by factors including patient s vein depth amount of adipose tissue age physical condition and skin condition traits e g scarring tattoos and hair These factors may completely prohibit veins from being displayed Standard visual and tactile methods and professional training should be used to confirm vein depth and location Deep veins in excess of about 7mm may not be visible VueTek Scientific Operator s User Manual Using Veinsite on subjects in a bassinet or incubator while viewing through the acrylic or polycarbonate such as Plexiglas may cause artifacts such as rings or patches of blurring that block out part of the displayed image This is caused by ambient conditions such as a heating lamp and the reflective properties of the plastic In an attempt to correct this the user may try changing the viewing angle of the Veinsite In all cases do not rely solely on the Veinsite display for performing the venipuncture or vascular access procedure Follow standard conventional clinical verification and implementation of the procedure using direct line of sight to the subject The VGA compatible video monitor must be certified for use with medical equipment IEC 60601 1 Furthermore all configurations shall comply with the medical system requirements IEC 60601 1 2005 Clause 16 or IEC 60601 1 1 2000 A user connecting additional equipment to data ports configures a medical system and is
9. able components on this device Servicing is to be performed only by the manufacturer or their authorized service centers Other servicing voids the warranty Read and observe all electro magnetic compatibility EMC limits as outlined in Appendix A in this manual Do not use this device near equipment with strong magnetic or electromagnetic fields such as MRI or CT equipment Remote Monitor Safety A CAUTIONS Follow all user instructions that accompany the monitor regarding safe product use Route cable to avoid contact with the patient and all sterile fields Route cable to avoid accidental tangling pulling or tripping Disconnect the Veinsite from external monitor when cleaning When using the external monitor feature the connected monitor may experience a momentary flicker due to AC electrical disturbances The internal display of the Veinsite will not be affected VueTek Scientific Operator s User Manual Clinical Analysis Clinical study results demonstrated that when using the Veinsite at least two 2 additional suitable IV sites were observed that had not been seen by the eyes and tactile feel This was demonstrated at above a 99 5 confidence level The study also demonstrated that subject gender subject group subject weight normal or overweight subject ethnicity subject skin tone or the viewing order did not affect the results i e ability to observe additional potential suitable IV sites versus the eye and tac
10. al i 2kV Common Fr Direrenial commercial or hospital environment Voltage Dips Dropout gt 95 Dip for 0 5 cycle 60 gt 95 Dip for 0 5 cycle 60 Mains power quality should be that of a typical EN IEC 61000 4 11 dip for 5 cycles 30 dip for dip for 5 cycles 30 dip for commercial or hospital environment 25 cycles gt 95 dip for 5 25 cycles gt 95 dip for 5 seconds seconds Power Frequency 60 60Hz 3A m 3A m Power frequency magnetic fields should be that of a magnetic field EN IEC typical commercial or hospital environment 61000 4 8 Recommended Separation Distances between portable and mobile RF Communications equipment and the Veinsite Equipment and Systems that are NOT Life supporting The Veinsite is intended for use in the electromagnetic environment in which radiated disturbances are controlled The customer or user of the Veinsite can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF Communications Equipment and the Veinsite as recommended below according to the maximum output power of the communications equipment Separation m 150kHz Separation m 80 to Max Output Power Watts to 80MHz D 3 5 V1 Sqrt 800MHz D 3 5 E1 Sqrt P P Separation m 800MHz to 2 5GHz D 7 E1 Sqrt P Compliance Electromagnetic Environment calculated listed below EV baa s e sar P Radiated RF EN IEC 61000 4 3 3 V m 80 MHz to 2 5 GHz E1 V m D 3 5 E1 Sqrt P 8
11. conditions CAUTION When using the remote monitor feature refer and adhere to all instructions paying special attention to the warnings and cautions found in the section on Remote Monitor Safety Figure 6 Use of Remote Monitor Cable VueTek Scientific Operator s User Manual Maintenance amp Support The Veinsite does not require any periodic maintenance other than routine cleaning There are no user serviceable components within the device other than battery replacement Order replacement and additional batteries from your distributor Replacing Disposable Headband Pads The pads located on the head basket straps can be removed and replaced as desired Replacement pads may be ordered from your distributor and are available in varying quantities The pads are attached to the head basket with Velcro strips To remove the pads simply peel away the old pads and discard Replacing the pads consists of simply pressing the new pads into the areas indicated in figure 7 Observe the correct side of the pad to attach to the Velcro strip The rough side should be against the strap the smooth side to the user s head Fig 7 VueTek Handling and Storage CAUTION Always keep the Veinsite and charger out of reach of children When not in use power off the Veinsite to preserve battery life If the Veinsite is not to be used for an extended period of time VueTek recommends removing the battery prior to storage Alwa
12. ded to be used as a diagnostic device or as a form of treatment It is not intended for imaging eyes vasculature in the eye or other structures of the eye It is not intended for tissue differentiation It is not intended to enable direct or indirect medical procedures Patient and User Safety A WARNINGS The Veinsite is for use by qualified medical personnel only The Veinsite is a visual aid and is not intended to replace the medical judgment of a qualified healthcare professional or the standard visual and tactile vascular access location confirmation process The Veinsite is a visual aid and should not be solely relied upon when performing vascular access procedures as a slight delay and difference in actual size of the vasculature in the display may be experienced The Veinsite does not distinguish between arteries and veins Use conventional visual and tactile methods to discriminate between arteries and veins The Veinsite does not display the depth of veins which can vary based on patient physiology condition and location of the anatomy being examined Standard visual and tactile methods and professional training should be used to confirm the vein depth and location Certain veins may appear larger than they actually are due to patient characteristics such as vein depth and amount of adipose fatty tissue Standard visual and tactile methods and professional training should be used to confirm vein size depth and location
13. ek Scientific Operator s User Manual Wearing the Device recommended that the Veinsite be cleaned and or the disposable headband pads be replaced between users It is also recommended that sanitary head covering such as a disposable bouffant be used while operating the device CAUTION To reduce the potential of contaminant transmission it is After placing the Veinsite device on the head the head basket fit is adjusted by grasping the adjustment knobs and turning clockwise to tighten and counter clockwise to loosen see Adjustment Knobs Figure 3 With the device powered on place the unit onto your head Adjust the top adjustment knob so that the display is aligned horizontally with your eyes Hold the unit in position to maintain horizontal alignment and adjust the rear knob of the device so that the strap will fit easily onto your head Increase the tension of the rear adjustment knob to achieve a snug and secure fit For a more precise view of the display repeat previous steps making minor adjustments of the entire unit up or down on the forehead N N N A Figure 4 Representation of Screen to Eye Positioning Vertical Adjustment Front to Back Adjustment Figure 3 Headband Adjustments Using the Device e _ Y c oeaeaaaonn Operator s User Manual English The Veinsite is a visual aid designed to be used in conjunction with conventional clinical practice With a
14. he Warranty Period 1 Twelve 12 months for each Veinsite vascular imaging device and 2 Ninety 90 days for any Veinsite battery 2 Notice of Warranty Claim If at any time during the applicable Warranty Period the Customer believes that the Equipment does not comply with any of the Warranties the Customer shall promptly notify VueTek of a Warranty Claim If the Customer does not provide notice of Warranty Claim within the Warranty Period the Customer shall not have any right to claim that the Equipment does not comply with the Warranties The Customer shall inspect the Equipment promptly after delivery to the Customer and promptly notify VueTek of any alleged breach of any Warranties or any errors relating to the delivery of the Equipment 3 Repairs and Replacements lf within the applicable Warranty Period the Customer notifies VueTek that any Equipment does not comply with any of the Warranties and if in fact the Equipment does not comply with any of the Warranties not caused by misuse or abuse VueTek shall at VueTek s election and expense either repair or replace the Equipment The Customer shall not return any Equipment to VueTek without first obtaining a return authorization number from VueTek or VueTek s authorized distributor If Customer fails to follow all of VueTek s return instructions including the packaging of the Equipment the repair will not be covered by this Warranty o Appendix A Electro magnetic Co
15. insite or its accessories using heat steam or pressure Do not allow any liquids to enter into any connectors or into the device itself Use only a cloth dampened with the cleaner to clean the device Veinsite Specifications uni we asozitoKg asteyenrgetme 200 minutes typical Rpprox stem shipwat7ibs 3 2Kg isplay LCD I II Illumination wavelength Illumination wavelength 850nm 850nm Battery type Sealed 7 4V lithium ion Exposed materials Nylon ABS polycarbonate 240 minutes 4 hours Battery charger input Battery run time typical ere 100 240 VAC 50 60 Hz Min Max operating temperature 32 F 90 F 0 C 32 C Humidity Operating Humidity Operating Humidity Operating 0 80 RH 80 RH Si Max storage Humidity Storage 0 95 RH tamersure __ F 122F 200 500 fone cm Veinsite Standards CIE S009 IEC 62471 Photobiological Safety of Lamps and Lamp Systems ANSI RP27 3 Recommended Practice for Photobiological Safety for Lamps Risk Group Classification IEC 60601 1 Medical Electrical Equipment Performance and Safety IEC 60601 1 1 Medical Electrical Equipment Safety IEC 60601 1 2 Medical Electrical Equipment Electromagnetic Compatibility nn IA VueTek Scientific Operator s User Manual Veinsite and Accessories Ordering Information VEINSITE Headset Vein Viewing System VTS1000 BAT Battery Pack VTS1000 CHARGER Battery Charger Base Power Supply Set VTS1000 VGA 4 8 meter Remote Monitor Video Cable
16. mpatibility Declarations Emissions All Equipment and Systems The Veinsite is intended for use in the electromagnetic environment specified below The customer or user of the Veinsite should ensure that it is used in such an environment RF Emissions CISPR 11 Group 1 The VTS1000 Veinsite 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 electronic equipment RF Emissions CISPR 11 N A Harmonics IEC 61000 3 2 Class A B C D or N A Class A when using VGA cable and external monitor Class B otherwise The VTS1000 Veinsite is suitable for use in all establishments including domestic and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes CAUTION When using the external monitor feature the connected monitor may experience a momentary flicker due to AC electrical disturbances The internal display of the Veinsite will not be affected A Immunity All Equipment and Systems munity Test EN IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance ESD Floors should be wood concrete or ceramic tile If floors EN IEC 61000 4 2 TORV cola SORY AI SONN COMAC SORY AT are synthetic the r h should be at least 30 RH EFT EN IEC 61000 4 4 2kV Mains 1kV I Os 1kV Mains 1kV I Os see justification oa 1kV Differential Mains power quality should be that of a typic
17. ntents ensure that your kit contains all of the items and visually inspect for any damage or missing items Contact VueTek prior to use if any items are missing or appear to be damaged Item Veinsite Head Set Carrying Case Headband Replacement Pad Operator s User Manual OUM Battery Battery Charger System Includes charger base and wall transformer gt B A N WARNING Do not use the Veinsite or its accessories if damaged Setting up the Battery Charger The battery charging system consists of a charging cradle to accept the battery and a wall mounted power supply to provide power to the cradle The power supply comes standard with several different terminal adapters to be compatible with many international power configurations Select the proper adapter for the appropriate power outlet and insert the adapter into the power supply housing There should be an audible click when the adapter is correctly mated with the power supply The charging cradle can be either wall or table top mounted If the cradle is to be wall mounted self adhesive pads are supplied that can be attached to the back of the cradle to hold the device to the wall For a more secure attaching method screws and anchors are also supplied for permanent mounting A detailed diagram can be found in the cradle s shipping package Connect the power supply with the correct power adapter in place to a suitable 110 240 VAC 50 60Hz wall outlet The indicator ligh
18. ross contamination between users Do not wear the headset for a prolonged period or if you experience any strain including to the neck or eyes Always keep the unit charger and battery out of the reach of children General Equipment Safety A WARNINGS Operator s User Manual English To avoid the risk of electrical shock inspect the battery charger cable and plug for damage before use Do not use the Veinsite or accessories if damaged Use only VueTek Scientific supplied batteries chargers and accessories In the event of visible damage do not use and contact VueTek Scientific for replacement Do not use the battery charger or insert or remove the battery pack from the Veinsite in an oxygen enriched environment A CAUTIONS Do not scratch the Veinsite protective lens cover or internal LCD display screens Use only non abrasive lint free materials to clean the device Clean the Veinsite between users If prior to or during the procedure no contrast between the vascular system and surrounding tissue is noted or if other anomalies are detected discontinue use of the device and contact VueTek for assistance Do not immerse any component of the Veinsite including battery charger batteries and remote monitor cable if used in water or other liquids Do not insert any objects into any opening on the Veinsite Dispose of batteries and accessories per your facility policy or local regulations There are no user service
19. s Used This manual and device packaging uses internationally accepted conventions in describing information requiring further attention by the user WARNINGS Indicate a hazardous situation which if not avoided or adequate precautions taken could result in loss of life or serious injury to the user or patient and potential device damage CAUTIONS Indicate a hazardous situation which if not avoided or adequate precautions taken could result in minor or moderate injury to the user or patient or device damage Caution consult accompanying Dispose of accordingly documents Manufacturer Allowable humidity range Allowable temperature range Consult instructions for use p 9 Fragile handle with care MRI Unsafe Temperature limitation Unit Power Switch Quantity Contrast Mode aHED gt gt 0 oa Keep dry 2 Operator s User Manual English Indications The Veinsite is a non invasive electronic device to aid in the visualization of superficial subcutaneous vasculature It is indicated for use in procedures requiring vascular or peripheral vessel access It is intended for use in settings such as hospitals ambulatory surgery centers blood drawing centers diagnostic or donation clinics outpatient treatment centers and office based physician practices Users of the Veinsite must be medical professionals qualified to perform vascular access procedures Contraindications The Veinsite is not inten
20. t in the base will glow red indicating power is available but no battery is detected Charging the Battery VueTek Scientific Operator s User Manual WARNING Do not perform battery operations inserting removing charging in an oxygen enriched environment Batteries are shipped in a partially charged state Prior to first use it is recommended that a full charge be done to ensure full use of the device Insert battery into charger cradle which causes the indicator light to blink green indicating that charging has begun Charging is complete when the indicator light turns steady green approximately five hours for full charge A fully charged battery will provide approximately 4 hours of continuous operation The indicator light can have four possible states as follows Solid Red No battery detected Blinking Red Fault condition battery or charger defective Blinking Green Charging Solid Green Fully charged To ensure that you always have a fully charged battery pack available it is recommended that a second battery pack be acquired to allow the use of the Veinsite while the depleted battery is being charged Installing Removing the Batteries CAUTION Do not use batteries if visibly damaged or the charger station indicated a faulty battery Inspect the battery and contacts for contamination such as dust and dirt that could prevent proper electrical contact If necessary clean with a non abrasive lint free wipe
21. tile feel of using the device This was demonstrated at above a 95 confidence level When further comparing the study results with subject age groups weight normal or overweight as a function of BMI ethnicity and skin tone that the number of potential IV sites observed was greater more beneficial when compared to visual methods with the following results e The observation of adult elderly subjects was more beneficial i e more suitable IV sites identified with the Veinsite than observing IV sites of neonate toddlers and adolescents e Observing IV sites of subjects with BMI equal or greater than 25 was more beneficial i e more suitable IV sites identified with the Veinsite than to observe IV sites of subjects with BMI less than 25 Observing IV sites of subjects with BMI equal or greater than 30 is more beneficial i e more suitable IV sites identified with the Veinsite than to observe IV sites of subjects with BMI less than 20 e Observing IV sites of Black or African American subjects was more beneficial i e more suitable IV sites identified with the Veinsite than to observe IV sites of White or Caucasian subjects Light Emissions The Veinsite infra red IR light emissions do not pose a potential hazard to the eye under any conditions of intended use and is exempt in accordance with ANSI RP27 3 and IEC 62471 2006 standards addressing optical safety hazards associated with LED IR Radiation However as with any
22. tput port for connecting an optionally supplied VGA Cable part number VTS1000 VGA to an external display monitor By using this cable with a suitable monitor observers can view in real time what the user of the Veinsite is seeing through the device To connect the Veinsite to an external display a Slide the cable s molded clip onto the top ridge of the Veinsite as shown in Fig 6 Loop the cable through the clip allowing additional safety in the event the cable is pulled b With the Veinsite turned OFF gently pry open the protective cap on the left side of the unit exposing the VGA connection c Insert the molded connector on the cable into the receptacle in the unit The molded connector should fit snugly into the recess where the protective cap fits Do not force the connector or twist after insertion d Attach the other end of the VGA cable to an appropriate input of a monitor and secure the support screws Note that the Veinsite transmits a VGA compatible signal to a monitor capable of receiving such a signal This includes all standard LCD Plasma and projector devices PCs and laptops are not typically capable of receiving a signal and therefore are not compatible with the Veinsite device e Turn the Veinsite on The image will be simultaneously shown in the headset and the external monitor The image on the monitor may differ from what is visible in the Veinsite s display due to monitor settings and external lighting
23. veins v II Redefining the standard for vascular imaging Operator User Manual SCIENTIFIC 7 Document Part Number VTS1000 OUM E Revision 1 6 English VueTek Scientific LLC ual 22 Shaker Rad Gray Maine 04039 USA 207 657 6565 TEL 207 657 6569 FAX www vuetekscientific com CE ec ner CEpartner4U BV ESDOORNLAAN 13 3951DB MAARN THE NETHERLANDS www cepartner4u eu VueTek Scientific and Veinsite are trademarks of VueTek Scientific LLC All contents of this manual are the proprietary copyright property of VueTek Scientific LLC and are subject to change at the discretion without notification by the manufacturer No parts of this manual may be copied transmitted or disseminated to other parties without express written permission from the manufacturer Copyright violations will be prosecuted to the full extent permissible by U S and International laws by VueTek Scientific LLC VueTek Scientific Operator User Manual Table of Contents a INTRODUCTION SAFETY amp CLINICAL CONVENTIONS USED INDICATIONS CONTRAINDICATIONS PATIENT AND USER SAFETY GENERAL EQUIPMENT SAFETY REMOTE MONITOR SAFETY CLINICAL ANALYSIS LIGHT EMISSIONS o o 0 YN Q UV UU vu A A USE IN OXYGEN ENRICHED ENVIRONMENT SETUP amp USE OF DEVICE UNPACKING amp INSPECTION SETTING UP THE BATTERY CHARGER CHARGING THE BATTERY INSTALLING REMOVING THE BATTERIES DEVICE CONTROLS AND IMPORTANT FEATURES REMOVING PROTECTIVE LENS COVERING
24. working distance of approximately 10 to 20 inches 25 to 50 cm from the patients anatomy the device provides hands free operation to complement current methods of vein identification a Look into the display for an enhanced view of the vasculature see Figure 5 b Look below the unit to allow normal vision and follow normal clinical practice C Alternate between a and b as necessary Normal viewing Instrument based viewing Figure 5 WARNING Do not rely solely on the Veinsite display for performing the venipuncture or vascular access procedures If prior to or during the procedure no contrast between the vascular system and surrounding tissue is noted or if other anomalies are detected discontinue use of the device and contact VueTek for assistance The Veinsite is designed to be used in a wide range of lighting conditions including fluorescent incandescent and natural lighting As the device provides its own light source a dimly lit room will not affect the efficacy of the Veinsite In extremely bright conditions such as would occur in direct sunlight the image s contrast may be reduced If this occurs shade the area as much as possible to improve the image quality VueTek Scientific Operator s User Manual Controls amp Indicators The Veinsite contains a LCD display that presents the image to the user as well as several informational icons Battery Status Fault icon Contrast mode icon Image
25. ys store the unit in a safe secure location per your institution s guidelines Operate at 32 F to 90 F 0 C to 32 C and 0 80 relative humidity Store at 4 F to 122 F 20 C to 50 C and 0 95 relative humidity If carrying the unit for an extended distance it is recommended that the device be placed into its carrying case Store the device where it will not be accessible by children and untrained individuals o Operator s User Manual English Cleaning As the Veinsite is an optical instrument it is important to keep the optical surfaces clean of contamination for optimum image quality Periodically inspect the device and if necessary gently clean the front window that houses the camera and light sources Any cleaner that is recommended for glass is acceptable do not use cleaners that will leave a residue or abrasive as these will degrade the optical surfaces The device s housing can be wiped down using any common non abrasive chlorine or alcohol based cleaners normally found in a medical environment Do not allow any liquids to enter into any connectors or into the device itself Use only a cloth dampened with the cleaner to clean the device The headband pads may be cleaned or replaced as desired Additional headband pads may be purchased through VueTek Scientific or your supplier A CAUTIONS Do not immerse any portion of the unit or its accessories in liquids or disinfectants Do not sterilize the Ve
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