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USER GUIDE - CAREstream America

1. CHAPTER TWO SAFETY AND WARNINGS SYMBOLS USED GENERAL SAFETY AND WARNINGS SYMBOL DEFINITIONS CHAPTER THREE PRODUCT DESCRIPTION DETACHABLE PARTS CONTROL PANEL VEINVIEWER UNIT FRONT VIEW VEINVIEWER UNIT BACK VIEW VEINVIEWER VISION SSD UNIT FRONT VIEW cerent pente roten torri reinen rase cerne CHAPTER FOUR PRODUCT SET UP MOVING PROCEDURE VEINVIEWER PRODUCT SET UP VEINVIEWER VIS QINAIMD 1 15 INSTALLING VEINVIEWER VISION TNE OPTIONAL DESK 15 INSTALLING VEINVIEWER VISION 17 CHAPTER FIVE START UP PROCEDURE 19 POWERING VEINVIEWER POWERING VEINVIEWER CHAPTER SIX OPERATING INSTRUCTIONS FOCUSING PROCEDURE IMAGING MODES CHAPTER SEVEN DEVICE DISPLAY MESSAGES PROJECTED IMAGE DISPLAY BATTERY LED INDICATOR SOFTWARE VERSION CHAPTER EIGHT SHUTDOWN PROCEDURE sscccssssssstcesecesseeesnesesseesssesesseeensecenseeeseeseeesseeesseeeenseees 27 POWERING DOWN VEINVIEWER 27 POWERING DOWN VEINVIEWER VISIONNNP eee scueessagsecsiciea ee e EEEE 28 V VEINVIEWER VISION AND VISION USER GUIDE 020 300036 03 REV 1 2012 09 CHAPTER NINE MAINTENANCE
2. CHRISTIE USER GUIDE 020 300036 03 Rev 1 2012 09 Quick Reference Tips for VeinViewer Vision VeinViewer Vision Vision Press Projector Power Switch located on the Battery Cover e Vision T P Press the On Standby button located on the Control Panel The proper focal distance from the Head Unit to the assessment area is 13 inches 33cm There is a 1 inch 2 54 cm window in either direction where the image will remain in focus Position the Head Unit as close to perpendicular 90 as possible with the assessment area Placing the Head Unit close to the patient skin move away until the border text becomes legible Once in focus choose the desired imaging mode by pressing the Mode button Universal baseline imaging mode for all patients Fine Detail enhances small details to bring out finer vessels Helpful for pediatrics neo nates or sclerotherapy patients Size adjusts the image window to three different sizes Inverse inverts the colors within the image field to project green veins on a dark background For further assistance with VeinViewer refer to the Troubleshooting section Chapter 11 of this User Guide Or call Christie Medical Holdings Inc Customer Service at 1 877 SEE VEIN 1 877 733 8346 toll free 01 901 721 0330 international or e mail infoGveinviewer com CHAPTER INTRODUCTION INTENDED USE entuzae Asp
3. CLEANING CHAPTER TEN SERVICE amp SERVICEABILITY sscccssscsssseessecesesceseeeesscesseessseessseeeessesenseeesseesseesseeesseeenes 31 CHAPTER ELEVEN TROUBLESHOOTING eene eene eee en eene neenon tnn stern stein ss tns setas sse tns tns estne enn 32 CHAPTER TWELVE TECHNICAL SPECIFICATIONS CHAPTER THIRTEEN LIMITED WARRANTY eere eren eee en eene eene een senserat tnnt tns setas esten sten sten 43 V VEINVIEWER VISION AND VISION USER GUIDE 020 300036 03 REV 1 e 2012 09 Please carefully read the information in this User Guide in its entirety and review these materials periodically to ensure that you will be able to use VeinViewer confidently and correctly This User Guide is a reference for using VeinViewer Vision and Vision t does not provide training in venous identification or clinical practices The User Guide covers the preparation and use of VeinViewer and includes a table of contents to help you find the information you need If additional information is needed contact Christie Medical Holdings Inc at www VeinViewer com e mail infoQ VeinViewer com or call the VeinViewer Support Center toll free at 1 877SEE VEIN 1 877 733 8346 For international calls dial 01 901 721 0330 INTENDED USE VeinViewer Vision family is a non invasive electro optical visual aid de
4. Unit through insertion into a properly grounded receptacle Wall Mount Fixture Allows for optional wall mounting Q Desk Mount Fixture Allows for optional desk mounting Refer to the Chapter 4 for wall or desk mounting your VeinViewer Vision N V VEINVIEWER VISION AND VISION USER GUIDE e 020 300036 03 REV 1 2012 09 CHAPTER FOUR PRODUCT SET UP a VEINVIEWER VISION MOVING PROCEDURE Center the Yoke so that it is in line with the A CAUTION Post Ensure that the Head Unit is in line with e Check all parts for shipping damage the Arm and fold the Arm against the Post and inspect unit before using In case of damage DO NOT use VeinViewer and Move the lever upward on Wheel locks to contact the Christie Technical Support unlock the Wheels All Wheels should turn department for further instruction freely and smoothly Failure to comply may result in physical injury or property damage o Holding the Post below the Yoke move VeinViewer to the desired location MOVING VEINVIEWER VISION CAUTION Do not place hang or otherwise apply weight to the unit arm this may result in improper device loading and or device instability Failure to comply may result in physical injury or property damage Always put the Head Unit in the travel position when moving the VeinViewer Vision Failure to comply may result in physical injury or property damage M VEINVIEWER VISION AND VISION U
5. an electromagnetic environment in which radiated RF disturbances are controlled The user of VeinViewer can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and VeinViewer as recommended in the VeinViewer Technical Specifications in Chapter 12 and according to the maximum output power of the communications equipment 020 300036 03 REV 1 2012 09 SYMBOL DEFINITIONS Caution Date of manufacture Caution Risk of electrical shock 0 On Off system power switch Manufacturer On Standby gg Authorized representative in the SN EC European community Serial Number Protective Earth Transport symbol Operating Instructions Battery symbol Consult accompanying documentation This symbol appears blue on the product OHO ESS V VEINVIEWER VISION AND VISION USER GUIDE 020 300036 03 REV 1 2012 09 e CHAPTER THREE PRODUCT DESCRIPTION VeinViewer is designed for ease of use VeinViewer utilizes visible and near infrared light for vascular imaging to illuminate and project the subcutaneous blood patterns directly onto a patient s skin AVIN Active Vascular Imaging Navigation allows the user to assess multiple access points with a real time digital image The adjustable head can be positioned over any part of the anatomy leaving the clinician s hands free to perform the procedure our trade
6. declaration electromagnetic immunity CONTINUED Immunity Test IEC 60601 Test Compliance Level Electromagnetic Environment Guidance 30 dip in Ur or 25 cycles lt 5 Ur gt 95 dip in Ur or 5 sec Level Voltage dips short lt 5 Ur lt 5 Ur MAINS power quality should be that of a typical commercial interruptions and 59596 dip in Ur gt 95 dip in Ur or hospital environment If the user of VeinViewer requires voltage variations or 0 5 cycle or 0 5 cycle continued operation during power mains interruptions on power supply it is recommended that VeinViewer be powered from an input lines 40 Ur 40 Ur uninterruptible power supply or a battery 60 dip in Ur 60 dip in Ur IEC 61000 4 11 or 5 cycles or 5 cycles 7096 Ur 7096 Ur 30 dip in Ur or 25 cycles lt 5 Ur gt 95 dip in Ur or 5 sec 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 Ur is the AC MAINS voltage prior to application of the test level V VEINVIEWER VISION AND VISION USER GUIDE 020 300036 03 REV 1 2012 09 TECHNICAL SPECIFICATIONS CONTINUED Guidance and manufacturer s declaration electromagnetic immunity CONTINUED Immunity Test IEC 60601 Test Compliance Level Electromagnetic Environ
7. or improper use of VeinViewer will void the limited warranty Service may be done by an authorized Christie representative See limited warranty Chapter 13 for situations where warranty is voided Christie is committed to the quality of our products You can reach our VeinViewer Support Center with any questions or comments regarding service contract options in service training sales or support by visiting www veinviewer com emailing info veinviewer com or by calling 1 877 SEE VEIN 1 877 733 8346 toll free For international calls dial 01 901 721 0330 020 300036 03 REV 1 2012 09 CI VeinViewer Vision system power will The Head Unit power will not turn on Dome No imaging light vf 1 Make sure that the VeinViewer Battery No Battery status indicator light has been charged No illumination from the Head Unit 2 If the Battery does not have sufficient On Standby indicator charge you may operate VeinViewer No audible hum from fan inside the Vision by plugging the Power Cord into Head Unit a hospital grade or Hospital Only power vf 4 Check for damage to cables receptacle 2 Check that the Power Cord is firmly 3 Press tha topol ihe Projector Power plugged into the wall and into the Unit Switch symbol to turn on 3 Flip the Projector Power Switch to power VeinViewer on and off System power shuts down turns itself off 4 Press the Head Unit On Standby button 5 Verify that the Syst
8. C adaptor may become warm when in use but this condition does not indicate a malfunction If you need to transport the AC adaptor you should disconnect the Power Cord and let it cool before moving it 020 300036 03 REV 1 2012 09 POWERING VEINVIEWER VISION CONTINUED At initial setup connect the Power Cord to the AC adapter and then plug the Power Cord into a wall receptacle The Unit will power On when first plugged in After initial setup press the On Stand By Button once to turn VeinViewer on The VeinViewer image will project in Universal mode Size Mode Inverse V VEINVIEWER VISION AND VISION USER GUIDE 020 300036 03 REV 1 2012 09 e CHAPTER SIX OPERATING INSTRUCTIONS 23 FOCUSING PROCEDURE A CAUTION The Head Unit must be positioned as closely as possible to a 90 degree angle perpendicular to the surface of the patient s anatomy to be imaged otherwise the projected image may appear skewed or distorted The practitioner s line of sight should follow the projected imaging light as closely as possible Always be aware of the Arm s location when bending or stooping near the unit Ensure the system and Head Unit power are on 9 Raise the arm as shown Position head so that it is perpendicular 0 degree to the area to be imaged as shown The joint between the Head and the Arm is a 3 axis joint that allows 6 degrees of motion vertica
9. CARE VEINVIEWER VISION ONLY Do NOT attempt to open disassemble replace the Battery or service the Power Supply compartment VeinViewer Vision shall only be serviced by authorized service representatives Failure to do so could result in electrical shock serious injury or loss of life Estimated Battery continuous run time 2 5 3 hours Number of uses assuming 2 5 minutes per use estimated 70 uses before needing recharge Recharge Time estimated at 4096 of a total charge in 1 hour complete charge estimated at 4 hours recharge time To recharge VeinViewer plug the Power Cord into the Power Inlet on the Battery Case and a standard AC power outlet The Unit does not need to be powered on in order to charge Device may be used while recharging Placing Vision in standby mode when not in use helps to preserve the battery life When you have finished charging the Battery unplug Power Cord and wrap it around the Cable Holder NOTE Always keep the Power Cord with the VeinViewer Vision unit WARNING Do not store VeinViewer Vision in temperatures above 60 C 140 F V VEINVIEWER VISION AND VISION USER GUIDE Optimum battery storage is achieved at room temperature The battery will prevent further charge or discharge if exposed to high temperatures It is recommended that the battery is recharged if it is stored longer than 6 months To ensure safe use of VeinViewer periodic preventive inspection a
10. CT TO ELECTRICAL SHOCK FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL 60601 1 AND CAN CSA C22 2 NO 601 1 M90 RATING 100 240 VAC 50 60Hz 6 4A PRODUCT NAME VeinViewer Vision X MODEL NO 134 001113 01 MADE IN AUSTRIA PATENT NUMBER 5 969 754 PATENT NUMBER 7 239 909 013 101871 01 020 300036 03 REV 1 2012 09 CHAPTER THIRTEEN LIMITED WARRANTY 43 Contact Christie Medical Holdings Inc for Standard Limited Warranty and Terms and Conditions M VEINVIEWER VISION AND VISION USER GUIDE 020 300036 03 REV 1 2012 09 e This page left intentionally blank Federal Law restricts this device to sale by or on the order of a healthcare practitioner Christie Medical Holdings Inc 1256 Union Avenue Memphis 38104 USA 2011 2012 Christie Medical Holdings Inc 020 300036 03 Rev 1 2012 09
11. OWERING DOWN VEINVIEWER VISION TNP 9 Press the On Stand By Button once to turn off the VeinViewer Head Unit VeinViewer Vision should now be completely off The On Stand By indicator will turn off CAUTION When VeinViewer is not in use ensure Unit and Arm are folded towards the VeinViewer frame to prevent any type of injury and damage to the device CAUTION A pinch point exists between links in the Arm Refer to Pinch Points on page 19 Pinch Points may occur when positioning the Arm to the desired location or when returning the Arm to the folded position Make sure the hands and any part of the patient user and bystanders are clear of all Pinch Points before positioning the Arm or returning the Arm to the folded position M VEINVIEWER VISION AND VISION USER GUIDE 9 28 020 300036 03 REV 1 2012 09 CHAPTER NINE MAINTENANCE CLEANING This section is intended to assist you in effective cleaning of VeinViewer It is also intended to protect the delicate VeinViewer components during the cleaning process For more information about the compatibility of cleaning solutions for VeinViewer please contact Christie or your local VeinViewer representative Failure to adhere to the following recommendations could damage the Unit and void the warranty MN WARNING Always press the System Power Switch off and disconnect the VeinViewer Power Cord from the electrical outlet before cleaning Failure
12. Parts No applied parts any contact with the equipment is incidental MEDICAL EQUIPMENT WITH RESPECT TO ELECTRICAL SHOCK FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL60601 1 AND IEC60601 1 CAN CSA C22 2 NO 601 1 020 300036 03 REV 1 2012 09 TECHNICAL SPECIFICATIONS CONTINUED Guidance and manufacturer s declaration electromagnetic emissions VeinViewer is intended for use in the electromagnetic environment specified below The customer or the user of VeinViewer should ensure that it is used in such an environment Emissions Test Compliance Electromagnetic Environment Guidance RF emissions Group 1 VeinViewer uses RF energy only for its internal function Therefore its RF CISPR 11 emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions Class A VeinViewer 2 0 Vision and Vision are suitable for use in all establishments other CISPR 11 than domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Harmonic Class A Warning This equipment system is intended for use by healthcare professionals only emissions This equipment system may cause radio interference or may disrupt the operation EC 61000 3 2 of nearby equipment It may be necessary to take mitigation measures such as reorienting or relocating VeinViewer or shielding the
13. SER GUIDE 020 300036 03 REV 1 2012 09 9 CHAPTER FOUR PRODUCT SET UP T5 PRODUCT SET UP FOR VEINVIEWER 1 Install the 3 8 16 screw through the large L Bracket Base Plate Holder and Mount Column as shown A WARNING After installation or service and before any use ensure that the Desk Wall Mount is secure properly to the mounting surface 2 Torque the 3 8 16 Nut to 75 in lbs 8 5 N m otherwise serious injury or loss of life could result INSTALLING VEINVIEWER VISION gt CAUTION e Check all parts for shipping damage and inspect unit before using In case of damage DO NOT use VeinViewer and contact the Christie Technical Support department for further instruction Failure to comply may result in physical injury or property damage INSTALLING VEINVIEWER VISION P OPTIONAL DESK MOUNT For your convenience VeinViewer Vision is packaged desk mount ready For wall mounting you will need to convert the desk mount to the wall mount configuration Proceed to step 5 Maximum desk thickness is 2 5 in 6 35 cm A torque wrench is required to complete steps 2 Q 3and5 M VEINVIEWER VISION AND VISION USER GUIDE 020 300036 03 REV 1 2012 09 OPTIONAL DESK MOUNT nstall the 3 8 16 x 7 8 Flat Socket Cap Screw through the small L bracket as shown Torque the screw to 75 in lbs 8 5 N m Place the Base on top of the Desk surface as shown nsta
14. TER FOUR PRODUCT SET UP 18 INSTALLING VEINVIEWER VISION ARM 9 The Arm should be able to rotate freely and smoothly A A pinch point exists between links in the arm Refer to figure below for Pinch Points location Pinch point may occur when positioning the arm to the desired location or when returning the folded position Make sure the hands and any part of the patient user and bystanders are clear of all pinch points before positioning the arm or returning the arm to the folded position 3 Place the power supply in the Holder as shown WARNING Please ensure the Arm has been properly secured to the Mount Column If the Arm is not firmly secured the VeinViewer Vision may fall off and result in serious injury or loss of life CAUTION Do NOT lay the AC Power adaptor on a material that is sensitive to heat as the material may become damaged o Install the Arm into the Mount Column as shown Secure the Arm to the Mount Column using the 3 32 Allen wrench as shown M VEINVIEWER VISION AND VISION USER GUIDE 020 300036 03 REV 1 2012 09 9 POWERING VEINVIEWER VISION VeinViewer Vision may be operated by AC electrical outlet or battery power ANIME Inspect the Power Cord and Plug on VeinViewer Vision is shipped with a detachable Power Cord The Power Cord supplied acts as the MAINS disconnect device and is compliant for North American use VeinView
15. ate for all patients FINE DETAIL Used for viewing finer image details Helpful for pediatrics neonates or sclerotherapy patients e INVERSE Inverts the color within the image to project green veins on a dark background SIZE Adjusts projected image to one of three sizes M VEINVIEWER VISION AND VISION USER GUIDE 020 300036 03 REV 1 2012 09 9 CHAPTER SEVEN DEVICE DISPLAY MESSAGES 2 This section explains all of the messages that may appear while operating VeinViewer PROJECTED IMAGE DISPLAY Inverse Mode Icon 9 Battery Charge Level VeinViewer Vision ONLY Icon permanently displayed for VisionXTND Current Mode Product Name UNIVERSAL x Wall Power Icon Company Name TVSH3AINQ M VEINVIEWER VISION AND VISION USER GUIDE 020 300036 03 REV 1 2012 09 9 BATTERY LED INDICATOR VeinViewer Vision ONLY The Battery Indicator on the Control Panel of VeinViewer Vision indicates the charge level of the Battery when powered On LED DISPLAY MESSAGE Solid Green Unit powered On Solid Red Battery Level 2596 Blinking Red Battery Level 1096 Battery Indicator There is also a Battery Indicator symbol in the border text of the VeinViewer Vision s projected image to the right of the Mode name Refer to image sample in this chapter Refer to Battery Care Chapter for battery charging procedure SOFTWARE VERSION The VeinViewer software version is dis
16. communications equipment transmitters and VeinViewer as recommended below according to the maximum output power of the communications equipment Rated Maximum Output Separation Distance According to Power of Transmitter Frequency of Transmitter m Ww 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz 3 5 j 3 5 Zu d WP d JP d P ia 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 17 1 17 2 33 10 3 69 3 69 7 38 100 11 67 11 67 23 33 For transmitters rated at a maximum output power not listed on the preceding page 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 V VEINVIEWER VISION AND VISION USER GUIDE 020 300036 03 REV 1 e 2012 09 EQUIPMENT CLASSIFICATION oii t US Protection against electrical shock Vision Class Equipment with no applied part e Vision Class Equipment with no applied part Protection against ingress of liquids Ordinary Equipmen
17. ed with this product or optional equipment Failure to comply may result in physical injury or property EIMEL GA 020 300036 03 REV 1 2012 09 CHAPTER TWO SAFETY AND WARNINGS NOTICES 2 ACCESSORIES WARNING VeinViewer components are specifically designed and manufactured for use in conjunction with VeinViewer Accessories designed by other manufacturers have not been tested by Christie and are not recommended for use with VeinViewer products DO NOT connect any other medical devices directly to the VeinViewer unit This could cause unexpected failure of the device and the VeinViewer unit Observe the following safety precautions to obtain maximum personal safety and to protect your VeinViewer VeinViewer produces a bright light however it does not use a laser based illumination system AN Do not look directly into the imaging light source when the Head Unit power is on Due to the bright light output provide the patient hospital issued eye protection when imaging neonatal patients or when imaging vasculature around the eyes or on the scalp Refer to your institution s guidelines concerning eye safety procedures M VEINVIEWER VISION AND VISION USER GUIDE 9 AN nel Christie endeavors to supply a wide variety of VeinViewer products to meet the needs of the end user and patient however interpretation and final application of VeinViewer rests solely on the healthcare pro
18. em Ready indicator is vf If this occurs please press the Projector illurninatedand steady Power Switch into the off position and contact the VeinViewer Support Center for assistance V VEINVIEWER VISION AND VISION USER GUIDE 020 300036 03 REV 1 2012 09 e CH CH Flashing Indicators Battery Indicator Both green and red LEDs flashing vf The Battery Indicator will flash rapidly if there is a loss of communication 1 Power off VeinViewer 2 Power on VeinViewer 3 If the Battery indicator is still flashing please call the VeinViewer Support Center for assistance Solid Indicators On Standby Indicator and Battery Indicator Green On Standby Indicator and both Battery Status Indicators are illuminated Imaging light unexpectedly turns off Plastic shell of the Head Unit is hot to the touch Button pad is unresponsive vf 1 Power off VeinViewer and wait 20 minutes 2 Power on VeinViewer 3 If all the status indicators become illuminated again this is a sign of overheating Please shut down the Unit and call the VeinViewer Support Center for assistance M VEINVIEWER VISION AND VISION USER GUIDE e 2 Head Unit power will not turn on Red LED flashing or not illuminated Unit shuts down on its own or shortly after a full charge cycle when running on battery power A flashing red LED indicator while the Projection Unit is on means the Battery needs recharging immedia
19. er Vision comes included with a North American only Power Cord For destinations other than North America the distributor country or sales representative in the destination country is required to provide the appropriate detachable medical grade Power Cord This medical grade cord must be compliant with both the destination country s power requirements and the electrical requirements specified in the User Guide V VEINVIEWER VISION AND VISION USER GUIDE e a regular basis to avoid the risk of electrical shock and or fire hazard If the Power Cord and plug are or appeared damaged do NOT use the VeinViewer Vision unit and immediately contact the Christie Technical Support department for further instruction The VeinViewer Vision Battery comes partially charged and should be immediately ready for training purposes It is recommended that you charge VeinViewer overnight before beginning regular continued use 020 300036 03 REV 1 2012 09 operating by battery power skip steps 1 2 amp 3 9 Unwrap the Power Cord from the Basket 2 Insert the receiver power plug into the port located at the back of the Base of the Battery Case MN WARNING To avoid the risk of electrical shock the plug must be inserted into receptacles marked Hospital Grade or Hospital Only The Protective Earth wire must not be removed or defeated Ensure the Projector Power Switch is in the off position before inse
20. fessional using the device Christie recommends that the healthcare professional rely on standard healthcare practices prior to starting or during any type of medical procedure Do not touch strike or otherwise damage the glass lens of the Head Unit 020 300036 03 REV 1 2012 09 WARNING Do NOT expose VeinViewer to excessive moisture temperature or direct energy sources such as heat lamps Do NOT attempt to lift the VeinViewer Vision Do NOT stand on the base of the VeinViewer Vision this may result in device instability VeinViewer Vision may lose stability if tilted more than 10 degrees in the moving position or if tilted more than 5 degrees during normal use WARNING Special precautions exist for VeinViewer regarding electromagnetic emissions EMC VeinViewer shall NOT be used adjacent to or stacked with other equipment VeinViewer needs to be set up and put into service according to the EMC information provided in the Technical Specifications in this User Guide Failure to do so could result in an increase of electromagnetic emissions or decrease in electromagnetic immunity and or affect the safety and effectiveness of VeinViewer Vision which could result in injury or damage V VEINVIEWER VISION AND VISION USER GUIDE ANZ VeinViewer is not to be used near flammable agents or flammable anaesthetics mixtures with air or with oxygen or nitrous oxide CAUTION VeinViewer may be used in
21. ions for radio cellular cordless telephones and land mobile radios amateur radios AM and FM radio broadcasts and TV broadcasts cannot be predicted theoretically 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 that VeinViewer is used exceeds the applicable RF compliance level on preceding pages VeinViewer should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating VeinViewer Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m INTERFERENCE VeinViewer has been tested to comply with IEC radiated and conducted electromagnetic interference limits and therefore is not expected to cause interference with other devices used in the healthcare marketplace See Equipment Classification M VEINVIEWER VISION AND VISION USER GUIDE 020 300036 03 REV 1 2012 09 TECHNICAL SPECIFICATIONS CONTINUED Recommended separation distances between portable and mobile RF communications equipment and VeinViewer VeinViewer is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of VeinViewer can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF
22. links red when the Battery charge level reaches 10 Battery Indicator for VeinViewer Vision ONLY NOTE The Mode and Size buttons access the Device Information screen when pressed simultaneously V VEINVIEWER VISION AND VISION USER GUIDE 020 300036 03 REV 1 2012 09 e CHAPTER THREE PRODUCT DESCRIPTION 10 VEINVIEWER VISION UNIT FRONT VIEW o Control Panel Location of unit imaging and feature controls Head Unit Controls VeinViewer imaging and user functions located in the Head Unit Control Panel Arm Enables the user to extend the Head Unit vertically to the desired location Post Supports the Yoke of the Unit and Unit accessories o Basket Provides storage of the User Guide and Power Cord when not in use Power Cord Conducts power to Unit through insertion into a properly grounded receptacle Q Caution Label ARIN Maximum allowable basket weight is 2 lbs 1 kg Do not exceed this weight limit as this may result in device instability and or improper loading Failure to comply may result in physical injury or property damage M VEINVIEWER VISION AND VISION USER GUIDE 020 300036 03 REV 1 2012 09 9 VEINVIEWER VISION UNIT BACK VIEW Battery Cover Location of the Projector Power Switch Projector Power Switch Allows the user to toggle the VeinViewer power between On and Off mode Base 11 Wheel Enables transport of Vei
23. ll the 1 2 13 x 3 Socket Set Screw though the small L bracket and place the Rectangular spacer between the bottom of the desk surface and the Socket Set Screw Torque the Socket Set Screw to 75 in lbs 8 5 N m to secure the base to the Desk WARNING Do NOT mount the base to a cart or mobile device After installation or service and before any use ensure that the Desk Wall Mount is secure properly to the mounting surface otherwise serious injury or loss of life could result V VEINVIEWER VISION AND VISION USER GUIDE e 020 300036 03 REV 1 2012 09 MODEL VEINVIEWER 5 WALL MOUNTING HARDWARE IS NOT INCLUDED WARNING After installation or service and before any use ensure that the Desk Wall Mount is secure properly to the mounting surface otherwise serious injury or loss of life could result DO NOT mount VeinViewer Vision to unsupported wall board INSTALLING VEINVIEWER VISION OPTIONAL WALL MOUNT Q Install wall screws to large L Bracket as shown Mounting holes are 5 16 7 9 mm in diameter A torque wrench is required to complete step 3 2 Install the 3 8 16 x 1 Button head Cap through the large L Bracket Base Plate Holder and fo E Mount Column as shown Torque the 3 8 16 Nut to 75 in Ibs 8 5 N m M VEINVIEWER VISION AND VISION USER GUIDE 020 300036 03 REV 1 2012 09 CHAP
24. lly horizontally and rotating 180 degrees 3 Position the Head within a few inches of the assessment area and slowly move the Unit away to the focusing distance approximately 13 inches 33 cm from the unit lens to the target location o Focus is achieved when the text around the border of the image is clear and legible M VEINVIEWER VISION AND VISION USER GUIDE 020 300036 03 REV 1 2012 09 9 CHAPTER SIX OPERATING INSTRUCTIONS 24 Before proceeding to use VeinViewer on 9 The Image and Inverse mode will be the patient ensure VeinViewer is in focus and displayed in the border text within the familiarize yourself with the following imaging projected image Refer to Device Display modes and features Messages Chapter for image sample Inverse and Size features may be used with both Universal and Fine Detail Modes MN CAUTION e The VeinViewer image may show a slightly different vessel width than the size of the actual vessel This effect may vary from subject to subject from one location of the body to another and between imaging Activating one Mode will turn off the other Mode if currently in use modes Christie recommends that the healthcare professional rely on standard healthcare practices prior to starting or during any type of medical procedure IMAGING MODES The image mode can be changed by pressing the Mode Button located on the Control Panel UNIVERSAL Standard imaging modes Appropri
25. location Voltage Complies luctuation licker emissions EC 61000 3 3 V VEINVIEWER VISION AND VISION USER GUIDE 020 300036 03 REV 1 2012 09 TECHNICAL SPECIFICATIONS CONTINUED Guidance and manufacturer s declaration electromagnetic immunity VeinViewer Immunity Test IEC 60601 Test Level is intended for use in the electromagnetic environment specified below The customer or the user of VeinViewer should ensure that it is used in such an environment Compliance Level Electromagnetic Environment Guidance Electrostatic discharge ESD IEC 61000 4 2 6 kV contact 8 KV air 6 kV contact 8 KV air Floors or mount surface should be wood concrete or ceramic tile If floors are covered 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 environment earth IEC 61000 4 4 1 kV for input output lines Surge 1 kV line s to 1 kV line s to MAINS power quality should be that of a typical commercial line s line s or hospital environment IEC 61000 4 5 2 kV line s to 2 kV line s to earth V VEINVIEWER VISION AND VISION USER GUIDE e 020 300036 03 REV 1 2012 09 TECHNICAL SPECIFICATIONS CONTINUED Guidance and manufacturer s
26. marked EOP Eyes On Patient technique M VEINVIEWER VISION AND VISION USER GUIDE 9 A DETACHABLE PARTS CAUTION Please make sure the following items are included with your VeinViewer unit If any items are missing contact your VeinViewer representative or Customer Support Do NOT substitute any items with non Christie items Failure to comply may result in physical injury or property damage e Model Name VeinViewer Vision Power Cord P N P01625 Qty 1 User Manual e Model Name VeinViewer Vision D Head and Arm assembly AC Power Adapter P N 002 120597 01 and Power Cord P N 012 101975 01 Base Mount Hardware 3 8 16 x 1 Button head Cap For optional Wall Mount OTY 1 3 32 Allen Wrench OTY 1 Rectangular Spacer QTY 1 User Manual Not included Torque wrench Wall mounting hardware 020 300036 03 REV 1 2012 09 CONTROL PANEL On Standby Toggles the Head Unit between On and Standby Modes The Indicator illuminates when power is supplied and the Head Unit is turned on On Standby 6 e Mode Toggles between the Universal and Fine Detail Modes o Inverse Inverts the colors within the image field to project green veins on a dark background Size Adjusts the size of the projected image field o Battery Indicator Alerts the user to the charge level of the Battery llluminates solid red when the Battery charge level is at 25 The indicator b
27. ment Guidance Level Conducted RF 3 Vrms 3 Portable and mobile RF communications equipment should be used no closer to any part of VeinViewer including cables IEC 61000 4 6 150 kHz to 80 MHz than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 any P d 11 171V P 80 MHz to 800 MHz P 800 MHz to 2 5 GHz Radiated RF 3 V m 3 V m Where P is the maximum output power rating of the transmitter in watts W according to the transmitter IEC 61000 4 3 80 MHz to 2 5 GHz manufacturer and d is the recommended 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 V VEINVIEWER VISION AND VISION USER GUIDE 020 300036 03 REV 1 2012 09 TECHNICAL SPECIFICATIONS CONTINUED Guidance and manufacturer s declaration electromagnetic immunity CONTINUED 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 Field strengths from fixed transmitters such as base stat
28. nViewer The Wheel Lock allows the user to lock the Wheel in order to halt movement of the Unit 12 Serial Label Contains product serial number and manufacturer information V VEINVIEWER VISION AND VISION USER GUIDE 020 300036 03 REV 1 2012 09 VEINVIEWER VISION UNIT BACK VIEW CONTINUED Yoke Supports the Arm and Head Unit 14 Interface Cable Delivers power to the Head Unit PB 15 Battery Case Protects the Battery Location of the Power Inlet and Ground Stud 16 Power Inlet Connects to the Power Cord for conducting power to the Unit 17 Ground Stud For biomedical department testing V VEINVIEWER VISION AND VISION USER GUIDE 020 300036 03 REV 1 2012 09 VEINVIEWER VISION UNIT FRONT VIEW Control Panel Location of unit imaging and feature controls Head Unit Controls VeinViewer imaging and user functions located in the Head Unit Control Panel o Arm Enables the user to extend the Head Unit to the desired location AC Power Adapter AC to DC converter o Power Cord Conducts power to
29. nd maintenance need to be performed by an authorized service representative in accordance to VeinViewer Vision Service Manual 020 100932 XX DISPOSAL Please ensure that VeinViewer and its accessories are properly disposed of as inappropriate waste handling of this product may cause potential hazards to the environment and human health Do NOT expose to fire or dispose of in fire For more detailed information about recycling of this product please follow your institution s guidelines or contact your waste disposal service or Christie Technical Support 020 300036 03 REV 1 2012 09 CH R TEN Christie is committed to helping you get the greatest value from the use of your VeinViewer While VeinViewer is of high quality we do realize that from time to time you may need support for technical or user issues We are more than happy to help Please use the Troubleshooting chapter to determine the answer to your question or contact the VeinViewer Support Center by telephone by e mail or online VeinViewer Support Center Hours Monday Friday 8 00 a m 5 00 p m CST Email Email is accepted on a 24 hour basis info veinviewer com Web site www veinviewer com Telephone 1 901 721 0330 1 877 SEE VEIN 1 877 733 8346 toll free International 01 901 721 0330 Fax 1 901 721 0350 International 01 901 721 0350 M VEINVIEWER VISION AND VISION USER GUIDE e SERVICEABILITY Unauthorized
30. played by simultaneously pressing the Mode button and the Size button located on the Control Panel UNIT INFORMATION FIRMWARE SOFTWARE v HEAD SERIAL NUMBER VISHAOOOO PRESS MODE TO EXIT To exit the Software Version Screen press the Mode button V VEINVIEWER VISION AND VISION USER GUIDE 020 300036 03 REV 1 2012 09 e CHAPTER EIGHT SHUTDOWN PROCEDURE 27 POWERING DOWN VEINVIEWER VISION A Te N Before attempting to move VeinViewer make sure it is not plugged into any receptacle Wrap the Power Cord around the Basket as shown to prevent any tripping hazards AMZEI Electrical safety hazard exists if the Unit is not disconnected from MAINS and Projector Unit is not turned off o Press the On Stand By Button once to turn off the VeinViewer Head Unit 9 veinViewer should now be in Stand By mode The On Stand By indicator will turn off The Battery display icon will remain green 6 Press the top of the black Projector Power Switch located on the Battery Cover in the off position O If the Projector Power Switch is off and the Unit is left plugged into a power receptacle the system is charging e Unplug the Power Cord from the power receptacle The Unit is off when the Projector Power Switch is in the off position and the Unit is unplugged V VEINVIEWER VISION AND VISION USER GUIDE 020 300036 03 REV 1 2012 09 e CHAPTER EIGHT SHUTDOWN PROCEDURE P
31. rting the plug into the wall receptacle CAUTION Do NOT place the Power Cord where it can be tripped over or stepped on If operating by battery power always wrap the Power Cord around the basket e Insert the pronged plug into a wall receptacle o Press the top of the black Projector Power Switch located on the Battery Cover to turn the Unit on M VEINVIEWER VISION AND VISION USER GUIDE e 020 300036 03 REV 1 2012 09 POWERING VEINVIEWER VISION TND VeinViewer Vision is operated by AC electrical outlet A ENDING VeinViewer Vision is shipped with an AC Power Adapter and a detachable Power Cord inside the container The Power Adapter is rated specifically for VeinViewer Vision The Power Cord supplied acts as the MAINS disconnect device and is compliant for North American use Inspect the AC Power Adapter and Power Cord on a regular basis to avoid the risk of electrical shock and or fire hazard If the AC Power Adapter and Power Cord appear damaged do NOT use VeinViewer VisionX P and immediately contact the Christie Technical Support department for further instruction V VEINVIEWER VISION AND VISION USER GUIDE 9 Ae ile Before you connect VeinViewer to a power source ensure that the voltage rating of the AC adapter matches that of the available power source Do NOT place the Power Cord where it can be tripped over or stepped on The surface of the A
32. t is not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide Mode of operation of equipment Continuous Operation a VeinViewer info veinviewer com Web site www veinviewer com l 5 l O n Toll Free 1 877 SEE VEIN 877 733 8346 e International 01 901 252 3700 C 0123 RATING 100 240 VAC 50 60Hz 1 3 0 7A PRODUCT NAME VeinViewer Vision U Em eL MEDICAL EQUIPMENT WITH RESPECT TO ELECTRICAL SHOCK FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL 60601 1 AND CAN CSA C22 2 NO 601 1 M90 33MX MADE IN AUSTRIA PATENT NUMBER 5 969 754 PATENT NUMBER 7 239 909 Emergo Europe EC Molenstraat 15 2513 BH The Hague The Netherlands Tel 431 70 345 8570 Fax 431 70 346 7299 Christie Medical Holdings Inc 1256 Union Avenue Memphis TN 38104 P01614 REV 3 J V VEINVIEWER VISION AND VISION USER GUIDE PATENTS VeinViewer is manufactured and sold under U S Patents 5 969 754 and 7 239 909 C EC REP Ci b s VeinViewer Vision FD Ce Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Tel 31 70 345 8570 Fax 31 70 346 7299 Christie Medical Holdings Inc 1256 Union Avenue Memphis TN 38104 info veinviewer com Web site www veinviewer com Toll Free 1 877 SEE VEIN 877 733 8346 International 01 901 252 3700 MEDICAL EQUIPMENT WITH RESPE
33. tely 1 Power off VeinViewer and connect it to AC power Let it charge overnight for a full charge 2 Power on VeinViewer and check Battery Status indicator light It should be solid green 3 Use VeinViewer normally If the red LED light begins to flash shortly after a full charge cycle this may indicate that the Battery needs to be replaced 020 300036 03 REV 1 2012 09 CHAPTER ELEVEN TROUBLESHOOTING Feature Buttons Mode Inverse Size No visible change in the image field or functionality when a feature button is pressed vf 1 Press alternate Keypad buttons to verify Keypad functionality If there is no Keypad functionality proceed to the Head Unit power solution 2 Make sure your finger is flush with Feature button 3 Press the Feature button making sure it is fully depressed Projected image appears out of alignment or unclear vf 1 Verify that the protective film has been removed from the Head Unit lens 2 Verify image focus Move the Head Unit up or down in order to obtain focal distance approximately 13 inches 33 cm from the target location The border text around the image should be clear and legible M VEINVIEWER VISION AND VISION USER GUIDE e 34 020 300036 03 REV 1 2012 09 CHAPTER TWELVE TECHNICAL SPECIFICATIONS 55 TECHNICAL SPECIFICATIONS Version Model Name Weight Clearance height with the Head Unit down Base Dimensions Arm Maximum Extension Po
34. tion VeinViewer is not to be used outside or in direct sunlight 020 300036 03 REV 1 2012 09 SYMBOLS USED Symbols are used in this manual and apply to hazards or unsafe practices which could result in personal injury or property damage See the information below for definitions of symbols WARNING Indicates a potentially hazardous situation which if not avoided could result in serious injury or loss of life CAUTION Indicates a hazardous situation which if not avoided may result in minor or moderate injury or damage GIVES IMPORTANT RECOMMENDATIONS AND INFORMATION FOR EFFICIENT TROUBLE FREE USE V VEINVIEWER VISION AND VISION USER GUIDE GENERAL SAFETY AND WARNINGS This safety section contains important information for the safe operation and use of this product WARNING DO NOT use this product or any available optional equipment without first completely reading and understanding these instructions and any additional instructional material such as service manuals or instruction sheets supplied with this product or optional equipment If you are unable to understand the warnings cautions or instructions within this manual contact Christie Customer Support before attempting to use this equipment Failure to do so may result in injury or damage WARNING DO NOT make any modifications to this equipment beyond the instructions provided in this manual or instruction sheets suppli
35. to do so may affect the safety and effectiveness of VeinViewer CAUTION Do not clean the glass lens with cleaning products or solutions other than 70 isopropyl alcohol Do NOT use solvents or abrasive cleaners on any part of the Unit Products and solutions other than those recommended may damage the Unit and will void the warranty M VEINVIEWER VISION AND VISION USER GUIDE 9 MN CAUTION 29 Do NOT spray cleaners or pour liquids directly onto the Unit surfaces Doing so may cause excessive fluids to enter and potentially damage the Unit Christie recommends the use of protective eyewear and gloves when cleaning the Unit Refer to your individual institution s policy and procedure for use of personal protective equipment while cleaning medical devices NOTE Cleaning methods listed are recommended for compatibility with Unit materials Cleaning frequency should be performed in accordance with your individual institution s infection control guidelines Lens The VeinViewer lens should be cleaned with a lint free cloth moistened with 7096 isopropyl alcohol ONLY o Allow to air dry or towel dry with a clean lint free cloth VeinViewer Body Q Use a SANI CLOTH PLUS or CaviWipes or 1 10 Bleach Wipes to wipe down all of the VeinViewer exposed surfaces 2 Allow to air dry or towel dry with a clean lint free cloth 020 300036 03 REV 1 2012 09 A BATTERY
36. vice designed to detect superficial blood under the skin and project an image of that blood pattern onto the surface of the skin of neonatal pediatric and adult patients Indications for Use VeinViewer Vision family is intended to image subcutaneous blood patterns on the surface of the skin The projected blood patterns may be interpreted by the clinician to determine intravascular or interstitial blood patterns such V VEINVIEWER VISION AND VISION USER GUIDE as blood within vessels e g veins the blood flowing through the vessels e g venous refill and or blood within the interstitial space e g hematoma The projected image pattern may also be used to demonstrate intravenous IV fluids displacing blood during IV flushes VeinViewer is intended to be used by trained Health Care Professionals including but not limited to Licensed Doctors Nurse Practitioners non CRNA Emergency Medical Technicians Registered Nurses Anesthesiologists Vascular Access Technicians and Phlebotomists Infusion Nurses to perform vascular access CONTRAINDICATIONS VeinViewer is not intended to be used for imaging of veins in the eyes in tissue differentiation as a diagnostic device or as a form of treatment VeinViewer is not intended to be used near equipment that may emit strong magnetic fields i e MRI equipment VeinViewer is not intended to be used to diagnose or verify the presence of a medical condi
37. wer Cord Battery Battery IR Wavelength peak Visible Wavelength peak Voltage Requirements Duty Cycle Operating Temperature Storage Temperature Version 2 0 Model Vision 53 5 Ibs 24 3 kg 60 152 4 cm 22x22 in 55 9x55 9 cm 25 63 5 cm US Medical Grade Power Cable Provided 6 cell Lithium lon Rechargeable Battery Approximately 850 nm Approximately 530 nm 100 240VAC 1 3 0 7A 50 60Hz Continuous 60 F to 90 F 16 C to 30 C 10 F to 140 F 23 C to 60 C Version 2 0 Model Vision 19 Ibs 8 62 kg N A Unit is stationary 6 x 5 5 15 3 x 14 cm Desk Mount 35 6 90 4 cm High Flex Power Cord provided N A Approximately 850 nm Approximately 530 nm 100 240 VAC 0 6 0 4 A 50 60 Hz Continuous 60 F to 90 F 16 C to 30 C 10 F to 140 F 23 C to 60 C V VEINVIEWER VISION AND VISION USER GUIDE e 0 to 90 non condensing Storage Humidity Atmospheric Pressure 700 hPa 1 060 hPa storage and operating 10 to 90 non condensing Operating Humidity Plastic Battery Cover Should only be removed by an authorized Christie representative Support VeinViewer Support Center Emission VeinViewer has been tested to and complies with IEC60601 1 2 standard for Electromagnetic Compatibility EMC and for radiated and conducted emissions Classified FDA Class 1 Exempt Regulatory Applied

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