Reference Guide - De Koningh Medical Products
Contents
1. USER MANUAL DKMP bv Arnhem NL 17 50 VascuLuminator 3186 GENO5 deHoningn m gt d i C L Reference guide p CO cd U C t S Date April 06 2011 2 General description 2 1 System description If a bodypart is held under the camera the display will show an image of that bodypart in grey tones If the infrared light source is held under the bodypart in such a way that the emitted light goes through the bodypart and into the camera the image will show the veins in the body part in dark tones as veins filled with blood obstruct the path of the infrared light The VascuLuminator consists of a stand that supports a swivel arm The swivel arm carries the display and camera An applicator is attached to the system emitting infrared light 2 2 Field of use Indications for use are patients that need a venipuncture in a thin body extension especially the hand in which the vessels are hardly or not at all visible or palpable or when the performer of the procedure needs a better vision in order to determine the location direction or size of the blood vessels in order to make a better judgment which vein or artery is suitable for puncture The VascuLuminator can be used for patients of any age weight health and condition 2 3 Use scenarios The VascuLuminator is a mobile device that can be moved to the patient area The swivel arm on the stand allows the user to bring the camera and display to the desired position w2. IR APPLICATOR However the infrared light is of a low intensity it is not recommended to look directly into the infrared light beam from close distance If any of the identification markings are removed before or during use please contact your service supplier The electronics inside the Vasculuminator will generate heat that will be dissipated through the IR adjustment knob on the camera the rear surface of the display and the infrared fiber connector on the rear side of the arm However these temperatures will be well below the limits that the safety regulations prescribe the surfaces will reach considerable temperatures See the Technical Description for the limits of use such as minimum and maximum temperature etc gt PPP PRP RPPP DKMP bv Arnhem NL 25 50 VascuLuminator 3186 GENO5 deHoningn Mm d C lt L Reference guide p CO qj U C t S Date April 06 2011 7 System overview W PERE 2 PGE ARATE PAMARRANEbSW hs PROREIERERGR PPP tl fl GE FIEENEIE PAPAL ts PRE FIEMIEERILGILE MA PAP bs BE APREA MEATA TEE rs PGA CEREA A ks BE A PRIR s 2 EEE 45 PEER xs Anam am W s PRL GRRL eak W EEIEI EEE Wis MARARA ARA PII W fl gt DKMP bv Arnhem NL 26 50 VascuLuminator 3186 GENO5 deHoningn Mm d C lt L Reference guide p CO qj U C t S Date April 06 2011 8 Installation instructions Caution before installation Do not remove the binder that keeps the ar
3. USER MANUAL 17 2 General description 18 2 1 System description 18 2 2 Field of use 18 2 3 Use scenarios 18 2 4 Contraindications 20 2 5 Operator level 20 2 6 Environment 20 2 7 Disclaimer 20 2 8 Application specification summary 20 3 Contents of the packaging 21 4 Explanation of packaging en product symbols 22 4 1 Explanation of packaging en product symbols 22 4 2 Type and position of labels warning signs and instructions 23 DKMP bv Arnhem NL 2150 VascuLuminator 3186 GENO5 deHoningn m gt d i C L Reference guide p CO cd U C t S Date April 06 2011 5 Safety and compatibility standards 23 6 Caution amp Warnings 25 7 System overview 26 8 Installation instructions 27 9 Operating instructions 30 9 1 Warnings 30 9 2 Controls 32 9 3 Use of the VascuLuminator 33 9 3 1 Charging the batteries 33 9 3 2 Using the VascuLuminator 33 The operator responsible for imaging 33 How to apply the VascuLuminator for imaging 34 IR applicator 34 Imaging 35 10 Cleaning instructions 37 11 Maintenance 37 12 TROUBLESHOOTING 37 13 Disposal 39 14 Storage amp maintenance 39 SERVICE MANUAL 41 15 SERVICE ACTIONS 42 15 1 Technical specification 42 15 2Installation instructions 42 15 3 Functions and operation 42 15 4Troubleshooting 42 15 5 Maintenance and inspection 42 15 6 Power supply cord replacement 43 15 7 Fuse replacement 44 15 8 Battery replacement 46 15 9IR applicator replacement 48 DKMP bv Arnhem NL 3 50 deHon
4. Turning the focus dial counter clockwise seen from above the focus distance is increased DKMP bv Arnhem NL 36 50 d K T VascuLuminator 3186 GENO5 e nNONingi o By R Stemerdink m gt d i C L Reference guide p O cd E C t 5 Date April 06 2011 Turning the focus dial clockwise seen from above the focus distance is decreased The focus can be adjusted to any distance between 0 1 and 0 8 m Turning the intensity dial counter clockwise seen from above the intensity is decreased Turning the intensity dial clockwise seen from above the intensity is increased 10 Cleaning instructions Before cleaning turn off the VascuLuminator and disconnect the power cord from the mains Clean the outer surface of the VascuLuminator including the IR applicator light source with a soft cloth of tissue dampened with a pH neutral disinfecting solution mild detergent or an ethanol 70 max Do not soak the activation button and do not spray detergents or other liquids directly on to the VascuLuminator Do not sterilize the VascuLuminator or the IR applicator by any means gt gt PPE 11 Maintenance In case any irregularities are detected in operating the VascuLuminator such as loose parts or malfunctioning the VascuLuminator should be inspected by qualified service personal Service actions are only allowed for qualified service personnel The only corrective actions that are allowed for the user are mentioned in cha
5. monostable The infrared intensity knob mounted on top of the camera The infrared light intensity can be adjusted by turning this knob manually The focus knob mounted on the bottom side of the camera The focus distance can be adjusted by turning this knob manually The screen giving a visual representation of the camera image in greytones The infrared applicator which is placed against a body part of the patient 1 8 Installation instructions For installation instructions see chapter 8 1 9 Estimated service life The estimated service life of the VascuLuminator is 5 years 1 10 Operator level Operator profile for operating the VascuLuminator is nursing personal at beginner and intermediate level who are used to handling medical equipment and who have the required skills and certifications to do injections and place drip needles 1 11 Service personnel level Service personal profile for servicing the VascuLuminator is technicians at beginner and intermediate level who are used to handling and repairing medical electrical equipment DKMP bv Arnhem NL 9 50 VascuLuminator 3186 GENO5 deHoningn m gt d i C L Reference guide p CO cd U C a S Date April 06 2011 1 12 Safety and compatibility standards For safety and compatibility standards see the user manual chapter 5 DKMP bv Arnhem NL 10 50 VascuLuminator 3186 GENO5 deHoningn m gt d i C L Reference guide p
6. the fiber end in the bush 15 10 Remaining items For information regarding electrical schemes component data etc please contact the manufacturer See chapter 19 for contact information DKMP bv Arnhem NL 48 50 VascuLuminator 3186 GENO5 deHoningn m gt d i C L Reference guide p CO cd U C t S Date April 06 2011 16 Modifications The VascuLuminator shall not be modified in any way 17 Disposal Do not dispose of this product in the unsorted waste stream Dispose of this product according to local regulations The product contains lead acid batteries that should be handled with care Waste batteries should not be short circuited Neither should their enclosing be damaged because they may spill sulphuric acid DKMP bv Arnhem NL 49 50 VascuLuminator 3186 GENO5 deHoningn m gt d i C L Reference guide p CO qj U C t S Date April 06 2011 18 Terms of warranty 18 1 General DKMS bv warrants that the VascuLuminator Vein imaging system will be free from defects in material and workmanship and will conform to DKMP bv applicable specifications If products sold hereunder are not as warranted DKMS bv shall at its discretion either refund the purchase price or repair or replace the product provided proof of purchase and written notice of non conformance are received by DKMP bv within the applicable warranty period The warranty set forth above does not extend to and shall not apply t
7. CO cd U C t S Date April 06 2011 DECLARATION OF CONFORMITY Manufacturer DKMP bv Simon Stevinweg 48 6802 EA Arnhem The Netherlands Product VascuLuminator Model nr 001 00 Serial nr 34811 001 Start production 22 September 2010 Classification Class IIa Rule 10 according to Annex IX of the MDD We hereby declare that the above mentioned product meet the provisions of the Council Directive 93 42EEC for Medical Devices All supporting is retained under the premises of the manufacturer Conformity assessment route according to Annex V VII Standards applied MEDDEV 2 7 1 REV 3 2009 NEN EN 1041 2008 NEN EN 980 2008 NEN EN IEC 60825 2008 NEN EN ISO 15223 1 2009 NEN EN 60601 1 2006 NEN EN 60601 1 2 2007 NEN EN 60601 1 6 2010 NEN EN IEC 62366 2008 NEN EN ISO 14155 1 2009 NEN EN ISO 14155 2 2009 NEN EN ISO 14971 2009 Issue of CE marking March 25 2011 Notified body DEKRA Certification bv 0344 Utrechtseweg 310 6800 ET Arnhem Place and date of issue Arnhem March 29 2011 H P Jansen v Galen QA manager SIGMAtUre O OOOO ela i VascuLuminator 3186 GENO5 deHoningn m gt d i C L Reference guide p CO qj U C t S Date April 06 2011 1 13 Electro Magnetic Compatibility Guidance and manufacture s declaration electromagnetic emissions The VascuLuminator is intended to use in de electromagnetic environment specified below The customer or the user of the VascuLuminator should assure that it is used in s
8. DEV2 7 1 rev 3 2009 Clinical evaluation Guide for manufacturers and notified bodies NEN EN ISO 60825 Safety of laser products DKMP bv Arnhem NL 24 50 VascuLuminator 3186 GENO5 deHoningn m gt d i C L Reference guide p O qj LU C t GS Date April 06 2011 6 Caution amp Warnings The VascuLuminator is designed for indoor use only Do not remove the binder that keeps the arm bend together until the arm is mounted and fixed on the VascuLuminator support clamp Removing the binder while the arm is not installed properly may cause unintended stretching of the arm Do not stand on the support of the VascuLuminator Do not attach any items onto the VascuLuminator The arm is not designed to carry any additional weight In stretched situation additional weight might overturn the VascuLuminator The VascuLuminator is only allowed to operate in combination with the dedicated VascuLuminator charger model 330 00 To avoid risk of electric shock this equipment must only be connected to a supply mains with protective earth The camera shall be in locked position using the camera clamp with the monitor facing towards the stand during travel of the VascuLuminator The VascuLuminator is designed to be moved around locally Traveling the system over greater distances and unsmooth floorsurfaces will increase wear on the wheels or might damage them When the VascuLuminator is in operation infrared light is emitted from the
9. Email info dkmp nl Website www dkmp nl CE 0344 DKMP bv Arnhem NL 50 50
10. Imaging 4 Align both hands to the imaging camera Imaging camera Align and move both hands towards the imaging camera 5 Move both your hands upwards approximately 10 15 cm towards the imaging camera te When the VascuLuminator is turned on a greytone image should now appear on the screen Keep a distance of approximately 10 to 15 cm from the camera DKMP bv Arnhem NL 35 50 de Koninan i m d C q L Reference guide By R Stemerdink p CO q U C t S Date April 06 2011 6 Optimise the image by adjusting distance intensity and focus Due to the approximate distance to the camera both dials need to be used to help optimise intensity and focus of the image To display a clear image of the desired point of venipuncture move the hand while turning the dials of the intensity and focus The VascuLuminator operator in this case will be adjusting the dials respectively with one hand wile moving the patients hand with the other To optimize the image both focus and intensity can be adjusted Imaging screen with a clear image of the veins in the hand The veins on the screen show up in greytones Dial to optimize image intensity Dial to optimize image focus 7 Turn the focus and intensity dials respectively to display a clear image of the veins in the hand ae D DA The intensity dial displays the following symbol The focus dial displays the following symbol
11. and is provided with a 1 5 A fuse The 6 A fuses are placed on the same side of the stand tube bracket The 1 5 A fuse is placed on the opposite side The type of the fuses is 6 x 32 mm 250Vac 125Vdc fastblow In order to replace a fuse the foot cover screws located on the bottom of the stand need to be removed The foot cover can then be lifted up in such way that the stand bracket with the fuse holders is accessible Make sure the swivel arm is in a locked position when tumbling the VascuLuminator in order to reach the screws located on the bottom of the system The camera should be locked in the clamp on the tube stand or a binder should be placed around the swivel arm segments to prevent it from stretching unintentionally To improve accessibility of the foot cover screws the VascuLuminator can be laid on its side Click the camera in the camera holder before doing so and lay the VascuLuminator on its side gently Mind that the swivel arm tends to move outward when it lays on its side as the weight of the camera and display no longer holds the arm down Remove the six screws of the foot cover Screws DKMP bv Arnhem NL 44 50 de Honingn m e d i cal Reference guide Version 7 0 By R Stemerdink p CO cd U C t S Date April 06 2011 Screws Put the VascuLuminator upright again Remove the 230V AC connector from the charger The foot cover can now be lifted up over approx 10 cm The fuse holders are now ac
12. atient to touch 1 5 Type and position of labels warning signs and instructions Information label On packaging General information storage and handling prescriptions Information label On charger Charger type and specification Information label On side of foot cover VascuLuminator specifications Warning label On top of foot cover Warning only to use charger model VascuLuminator 330 00 Warning label On top of foot cover Warning not to stand on foot cover Warning label On swivel arm binder Warning for unintended spring arm extension when in package Information engraving Fiber connector on arm BF class indication for applied part IR APPLICATOR backside of monitor Camera upper side Knob turning direction of IR intensity adjustment Indicator light On charger Charging status blue fast charging green trickle charging DKMP bv Arnhem NL 8 50 VascuLuminator 3186 GENO5 deHoningn m gt d i C L Reference guide p O qj U C t Date April 06 2011 Indicator light In on off button Battery status green charged yellow battery low 1 6 Software The VascuLuminator does not contain any dedicated software neither is it in any way programmable 1 7 Human machine interface The VascuLuminator contains the following interfaces with the user The on off button mounted on the display The button carries an indicator that lights green during normal operation and turns orange when the battery is low The button is
13. cessible 6A fuse 6A fuse 1 5 A The fuse holder can be opened by unscrewing the cap After replacement of the fuses check the function of the VascuLuminator If the replaced fuse blows again after a short time the VascuLuminator should be investigated by the manufacturer DKMP bv Arnhem NL 45 50 de Honingn Version 7 0 By R Stemerdink P C lt Reference guide p CO q U C t S Date April 06 2011 15 8 Battery replacement The batteries are maintenance free When the performance of the batteries decreases when they reach the end of their lifetime they shall be replaced with the same type batteries Model NP7 12 It is recommended to replace the batteries every 3 years In case of battery replacement the foot cover should be moved upward as far as possible to ensure accessibility of the battery compartment Remove the swivel arm as described before The six fastening screws of the foot cover should be removed see 2 1 Put the VascuLuminator upright again Remove the charger from its cradle and remove the charger cradle from the stand by unscrewing the two countersunk screws The foot cover can now be shifted along the stand tube When doing so be aware of the wires that lead to the charger connector Disconnect the connector see picture and remove the footcover connector under foot plate DKMP bv Arnhem NL 46 50 VascuLuminator 3186 GENO5 deHoningn m gt d i C L Ref
14. d H i T VascuLuminator 3186 GENO5 enoni noi o m P d C Reference guide By R Stemerdink p CO qj U C t S Date April 06 2011 VascuLuminator Vein Imaging system Reference guide i oe _ CE 0344 cu Distribution Date Version Status Description DKMS bv 27 10 2010 1 0 Concept First issue for comments no van Dc R Stemerdink uve 2 0 Releasse BF symbol added par 4 1 08 12 2010 3 0 Reiger ee Soe aie Technical File location BF symbol 15 12 10 4 0 Release MEPA TrA a ESA Technical File changes 05 01 2011 5 0 Release Palen Tonge never se elie Technical file described symbols added 28 03 2011 6 0 Release IR applicator assembly instructions vesnnlealie 06 04 2011 7 0 Release Declaration of conformity Technical file for approval R Stemerdink name signature H Jansen van Galen name signature DKMP bv Arnhem NL 1 50 VascuLuminator 3186 GENO5 deHoningn m gt d i C L Reference guide p CO qj U C t S Date April 06 2011 Index TECHNICAL SPECIFICATION 5 1 Technical specification 6 1 1 General specifications 6 1 2 Isolation from supply means 8 1 3 Operation mode 8 1 4 Applied parts 8 1 5 Type and position of labels warning signs and instructions 8 1 6 Software 9 1 7 Human machine interface 9 1 8 Installation instructions 9 1 9 Estimated service life 9 1 10 Operator level 9 1 11 Service personnel level 9 1 12 Safety and compatibility standards 10 1 13 Electro Magnetic Compatibility 12
15. e and operation of the VascuLuminator 15 4 Troubleshooting See the document part User manual chapter 12 for troubleshooting 15 5 Maintenance and inspection In case any irregularities are detected in operating the VascuLuminator such as loose parts or malfunctioning the VascuLuminator should be investigated by qualified service personal Service actions are only allowed for qualified service personal The only corrective actions that are allowed for the user are mentioned in chapter 12 Troubleshooting item 1a and 1b The VascuLuminator is designed for a service life of 5 years The performance of the batteries however may decline during the lifetime depending on the number and time of the charging cycles The batteries are replacement parts and if necessary they can be replaced by qualified service personal DKMP bv Arnhem NL 42 50 VascuLuminator 3186 GENO5 deHoningn m gt d i C L Reference guide p CO qj U C t S Date April 06 2011 15 6 Power supply cord replacement If the power cord is damaged it should be replaced by a proper power cord that complies to the applicable standards DKMP bv Arnhem NL 43 50 VascuLuminator 3186 GENO5 deHoningn m gt d i C L Reference guide p O qj LU C t Date April 06 2011 15 7 Fuse replacement The VascuLuminator is provided with 3 fuses Each battery has a 6 A fuse in the positive voltage line The power line that leads through the st
16. ect it to the mains after use to keep the batteries fully charged The operator responsible for imaging The operator of the VascuLuminator in an imaging situation is an operator experienced in dealing with patients in a clinical environment and used to performing venipunctures The operator will perform all imaging operations and guide the patients hand to optimally image the desired area for venipuncture Operations performed will be adjusting the intensity and focus and guiding the patients hand while observing the image on the display DKMP bv Arnhem NL 33 50 VascuLuminator 3186 GENO5 deHoningn m gt d i C L Reference guide p CO q U C t S Date April 06 2011 How to apply the VascuLuminator for imaging IR applicator 1 Align the IR applicator with the transparent side up When the VascuLuminator is turned on a red spot will be visible IR applicator Transparant side up Emission from the infrared source will radiate upwards 2 Place the hand for imaging above the IR applicator The radiant side of the IR applicator will now be facing the imaging hand 3 Press the IR applicator with the transparent side up to the imaging hand The radiant side of the IR applicator will now be lighting the imaging hand DKMP bv Arnhem NL 34 50 d K T VascuLuminator 3186 GEN05 e O N N Q Version 7 0 By R Stemerdink m e d l C L Reference guide p CO d LU C t Date April 06 2011
17. ectromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the VascuLuminator can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the VascuLuminator as recommended below according to the maximum output power of the communications equipment Rated maximum output Separation distance according to frequency of transmitter power of transmitter m 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz ff Fd d 3 NP d WP n E1 For transmitters rated at a maximum output power not listed above the recommended separation distance d i n 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 DKMP bv Arnhem NL 15 50 VascuLuminator 3186 GENO5 deHoningn m gt d i C L Reference guide p CO cd U C t S Date April 06 2011 DKMP bv Arnhem NL 16 50 VascuLuminator 3186 GENO5 deHoningn m gt d i C L Reference guide p CO cd U C t S Date April 06 2011
18. equency range IEC61000 4 3 3 V m 80 MHz to 2 5 Interference may occur in the vicinity of equipment GHz marked with the following symbol o 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 stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast 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 filed strength in the location in which the VascuLuminator is used exceeds the applicable RF compliance level above the VascuLuminator should be observed to verify normal operations If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the VascuLuminator P Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m DKMP bv Arnhem NL 14 50 VascuLuminator 3186 GENO5 deHoningn m gt d i C L Reference guide p O qj LU C t Date April 06 2011 Recommended separation distances between portable and mobile RF communications equipment and the VascuLuminator The VascuLuminator is intended for use in an el
19. erence guide p CO qj U C t S Date April 06 2011 Disconnect the red and black wires from the terminals Unscrew the brackets that hold the batteries hexagon socket M4x6 screws Replace the batteries See the Technical Specifications for the recommended battery type Place the brackets again and attach them with the M4 screws Connect the wires to the terminals with the corresponding colors Red Black Lower the foot plate and connect the Molex connector Place the foot cover back in its original position and place the foot plate screws and the charger cradle again Place the charger in the cradle with the 230 V connector facing downwards and connect the power cable in again Reassemble the swivel arm to the stand tube The first time that the VascuLuminator is used with the new batteries connect the charger to the mains in order to charge the batteries DKMP bv Arnhem NL 47 50 de Koninan gt m P d C c Reference guide By R Stemerdink p CO q U C t S Date April 06 2011 15 9 IR applicator replacement If the IR applicator needs replacement turn the two set screws in the fiber connection bush that is mounted on the suspension arm 2 turns anticlockwise and pull the fiber end out of the fiber connection bush set screws in fiber connection bush Push a the loose fiber end of a new IR applicator into the fiber connection bush as far as possible Turn the set screws clockwise to fix
20. f this product according to local regulations The product contains lead acid batteries that should be handled with care Batteries shall not be short circuited Neither should their enclosing be damaged because sulphuric acid may be spilled 14 Storage amp maintenance The batteries require an auxiliary charge refresh charge every 6 months when stored at temperature between 20 and 40 C The batteries are best to be charged at least within 6 months after manufacturing date DKMP bv Arnhem NL 39 50 VascuLuminator 3186 GENO5 deHoningn m gt d i C L Reference guide p CO cd U C t S Date April 06 2011 DKMP bv Arnhem NL 40 50 VascuLuminator 3186 GENO5 deHoningn m gt d i C L Reference guide ponies SERVICE MANUAL DKMP bv Arnhem NL 41 50 VascuLuminator 3186 GENO5 deHoningn m gt d C L Reference guide p O cd E C a GS Date April 06 2011 15 SERVICE ACTIONS A Before a service action is carried out the 230V AC mains must be disconnected Maintenance and repair is to be carried out only by qualified service personnel 15 1 Technical specification See the document part Technical specification chapter 1 1 to 1 12 for all technical data 15 2 Installation instructions See the document part User manual chapter 8 for installation instructions 15 3 Functions and operation See the document part User manual chapter 2 to 14 for intended us
21. fragile contents Do not step DKMP bv Arnhem NL 22 50 de Honingi med cal By R Stemerdink Reference guide p CO cd U C t S Date April 06 2011 Applied part is class BF Maximum and minimum storage temperature 40 C Maximum and minimum storage humidity 25 80 rH We B For indoor use only 4 2 Type and position of labels warning signs and instructions See chapter 1 5 5 Safety and compatibility standards The VascuLuminator is a Class lla medical device The VascuLuminator complies with the following standards IEC 60601 1 Medical electrical equipment safety IEC 60601 1 2 Electromagnetic compatibility EN 980 2008 Symbols for use in the labelling of medical devices EN 1041 2008 Information supplied by the manufacturer of medical devices EN ISO 13485 2003 Medical devices Quality Management Systems Requirements for regulatory purposes EN ISO 14971 2009 Medical devices Application of risk management to medical devices DKMP bv Arnhem NL 23 50 VascuLuminator 3186 GENO5 deHoningn m gt d i C L Reference guide p CO qj U C t S Date April 06 2011 EN 60601 1 6 2007 Medical electrical equipment Part 1 6 General requirements for safety Collateral standard Usability EN 62366 2008 Medical devices Application of usability engineering to medical devices EN ISO 14155 1 2003 Clinical investigation of medical devices for human subjects Part 1 General requirements MED
22. g with locking nut 7 Remove the binder holding the arm together 8 Mount the IR applicator into the applicator holder Push the metal bush on the end of the IR applicator cable into the fiber connection bush See following pictures metal bush DKMP bv Arnhem NL 28 50 VascuLuminator 3186 GENO5 deHoningn m e d i C c L Reference guide p CO q LU C t 5 Date April 06 2011 While pushing the fiber end in the bush turn the two set screws in the fiber connection bush clockwise to fix the fiber into the connection bush fiber connection bush on rear side of display arm set screws IR applicator fiber cable end WARNING be careful when tightening the set screws Turning with too much torque might damage the fiber end The set screws should be turned gently against the fiber end to prevent it from slipping out The VascuLuminator is now ready for use DKMP bv Arnhem NL 29 50 de Honingi med cal By R Stemerdink Reference guide p CO qj U C t S Date April 06 2011 9 Operating instructions 9 1 Warnings The VascuLuminator is designed for indoor use only Only move the VascuLuminator by holding the blue segment of the a VascuLuminator support as shown on the picture right e The VascuLuminator is designed to be moved around locally Moving the system over greater distances and unsmooth floorsurfaces will increase wear on the wheels or damage them Do not suspend anything from t
23. he swivel arm as this may damage the 5 PA VascuLuminator or make it instable l The VascuLuminator is designed only to be used with a battery charger model VascuLuminator nr 330 00 To avoid risk of electric shock this equipment must only be connected to a supply mains with protective earth The user is only allowed to perform the operations that are described in the user manual Maintenance and repair is to be carried out only by qualified service personnel The IR applicator shall be treated with care as its cable contains glass fibers which are vulnerable Do not bend the cable too tighly The electronics inside the Vasculuminator will generate heat that will be dissipated through the IR adjustment knob on the camera the rear surface of the display and the infrared fiber connector on the rear side of the arm However these temperatures will be well below the limits that the safety regulations prescribe the surfaces will reach considerable temperatures gt PPbbb PRP DKMP bv Arnhem NL 30 50 VascuLuminator 3186 GENO5 deHoningn m gt d i C L Reference guide p CO cd U C t S Date April 06 2011 DKMP bv Arnhem NL 31 50 VascuLuminator 3186 GENO5 deHoningn m gt d i C L Reference guide p CO qj U C t S Date April 06 2011 9 2 Controls 9 on off button with indicator green on and batteries are charged yellow on and batteries are low 10 InfraRed light inte
24. ingn medical products 15 10 Remaining items 16 Modifications 17 Disposal 18 Terms of warranty 18 1 General 18 2 Disinfection before shipment 18 3 Packaging 19 Contact information DKMP bv Arnhem NL VascuLuminator 3186 GENO5 Reference guide Date April 06 2011 Version 7 0 By R Stemerdink 48 49 49 50 50 50 50 50 4 50 deHoningn m gt d i C al Reference guide p CO cd U C t S Date April 06 2011 TECHNICAL SPECIFICATION DKMP bv Arnhem NL 5 50 deHoningn medical products VascuLuminator 3186 GENO5 Version 7 0 By R Stemerdink Date April 06 2011 Reference guide 1 Technical specification 1 1 General specifications Packaging dimensions Device dimensions Device weight excl packaging Field of use Storage temperature range Storage relative humidity Operating temperature Max Altitude Length of swivel arm Vertical camera adjustment Focus distance LED power Batteries Charger Charger input voltage Charger output voltage Fuses Protection class IR applicator DKMP bv Arnhem NL 69 x 53 x 102 cm 54 x 48 x 165 cm when in transport state 23 kg indoor use only 15 40 C 25 85 18 to 30 C 2000m above sealevel 1 05 m 0 5 01 65 m distance from floor level to camera 0 1 0 8 m 80 mW max NP7 12 Lead acid 12V 7 2 Ah size 95x151x 65 mm terminal size 4 8 mm main
25. ithout having to move the whole device The display arm can be rotated over almost 360 so that the optimal position of the display can be realized without having to move the device the swivel arm the patient or the user The camera and display can be tilted over 15 degrees in vertical direction for optimal visability The device can be switched on at any moment before or after positioning the device and the camera Switching off the device is allowed at any moment after use When using the device for a longer time the device is allowed to remain switched on See following schematic representations DKMP bv Arnhem NL 18 50 VascuLuminator 3186 GENO5 deHoningn m gt d i C L Reference guide p CO cd U C t S Date April 06 2011 The reach of the swivel arm enables the use of the VascuLuminator in several positions Examples 1 Both patient and user sitting on chairs the VascuLuminator being positioned somewhere aside of patient and user top view patient user VascuLuminator 2 The patient laying or sitting in a hospital bed the user positioned next to the bed top view patient user VascuLuminator 3 Young child laying in an incubator the user positioned next to the incubator top view incubator with child VascuLuminator DKMP bv Arnhem NL 19 50 VascuLuminator 3186 GENO5 deHoningn m gt d i C L Reference guide p CO qj U C t S Date April 06 2011 2 4 C
26. m bend together until the arm is mounted and fixed on the A VascuLuminator support clamp Removing the binder while the arm is not installed properly may cause unintended stretching of the arm Installation of the VascuLuminator 1 Slide the Swivel arm support clamp 4 over the Lower VascuLuminator support 3 2 Connect the plug that protrudes from the upper part of the VascuLuminator into the socket like shown 3 Shift the Swivel arm assembly 5 into the Distribution support be careful to not damage wires and connections Rotate the Distribution support and align the holes of the Distribution support with those of the Lower VascuLuminator support 4 Rotate the Swivel arm support clamp 4 to align all the holes 5 Mount the screw fixating the arm onto the stand 6 Connect the power cable to the battery charger and place the charger in the bracket A The power cord has to be at the bottom side of the cradle See following pictures DKMP bv Arnhem NL 27 50 deHoningn medical Reference guide B R Sener p CO cd U C a S Date April 06 2011 Correct installation Incorrect installation power cord upward and charger Power cord at bottom of cradle and charger cable downward Connect the charger plug into the stand Due to its shape the charger plug can only be mounted to the connector in one position After placing the connector turn the locking nut so that the plug is fixed in the connector plu
27. nsity adjustment knob 11 camera focus ring DKMP bv Arnhem NL 32 50 VascuLuminator 3186 GENO5 deHoningn m gt d i C L Reference guide p CO qj U C t S Date April 06 2011 9 3 Use of the VascuLuminator 9 3 1 Charging the batteries 1 Connect the power cord to the mains 2 The indicator on the charger should now become blue or green If the light is blue the charger is fast charging which means that the batteries needed recharging If the indicator is green the charger is trickle charging which means that the batteries are nearly filled or are completely filled and the charger is maintaining the battery charge The VascuLuminator is built for continuous operation When the batteries are fully charged the VascuLuminator can operate for at least 10 hours The batteries need to be recharged for at least 8 hours after this time by connecting the charger to the mains supply 9 3 2 Using the VascuLuminator 1 Turn the VascuLuminator on by pressing the on off button 9 The button will light up green when switched on An image will appear on the display after a few seconds Z If the button lights up yellow the batteries need recharging however the VascuLuminator can still be used for some time Recharging of the batteries in this case is recommended 3 After use switch off the VascuLuminator by pushing the on off button 4 If the power cord was detached during use it is recommended to reconn
28. o products which have been repaired or altered by persons other than DKMP bv personnel They also do not apply to products that fail or are damaged due to shipment handling or storage or operation use or maintenance in a manner or environment that does not conform to DKMP bv published instructions and specifications Batteries accumulators moving parts and failures due to such components are also excluded The warranty set forth above are in lieu of all other warranties expressed or implied statutory or otherwise including warranties of merchantability and fitness for a particular purpose which DKMP bv disclaims 18 2 Disinfection before shipment In case the VascuLuminator is returned to DKMP byv the device should be disinfected first using a cloth with 70 ethanol solution See chapter 10 for cleaning instructions The VascuLuminator should be accompanied by a signed document confirming that the device is disinfected before shipping In case this document is not send with the device the time required by DKMP bv for inspection and return of the device will be influenced 18 3 Packaging In case the VascuLuminator is returned to DKMP bv the original packaging should be used The IR applicator is vulnerable to bending and should be packed in the original protection box with foam inlay 19 Contact information De Koningh Medical Products bv Simon Stevinweg 48 6827 BT Arnhem The Netherlands Tel 31 26 3849021 Fax 31 26 3849066
29. ontraindications There is no contra indication for the use of the VascuLuminator 2 5 Operator level Operator profile for operating the VascuLuminator is nursing personal at beginner and intermediate level who are used to handling medical equipment and who have the required skills and certifications to do injections and place drip needles 2 6 Environment The VascuLuminator is ment for indoor use only The device is equipped with antistatic wheels and can be moved 2 7 Disclaimer The VascuLuminator is not intended for distinguishing veins from arteries The VascuLuminator may not visualize small vessels or vessels that lay deeper in the body Infrared light from the environment such as direct sun light and halogen light sources may have a negative influence on the resulting image The image on the monitor will show up over exposed Visible light sources typically used in hospitals will not diminish proper performance of the VascuLuminator 2 8 Application specification summary System description An infrared light source held under body part allows camera with infrared filter to detect the position of veins in the body part as blood is less translucent for infrared light than tissue A representation of the vein position is shown in greytones on a display Field of use Making the position of veins visible in thin body extensions esp hand when see required for venipunctures Operator level Medical personnel skilled and certified f
30. or doing injections and placing drip needles Use limitations limited visibility of smaller veins and veins that lay deeper in the body no diffirence in representation of veins and arteries direct sunlight and bright light sources may influence the quality of the representation on the screen DKMP bv Arnhem NL 20 50 deHoningn Version 7 0 By R Stemerdink gt C Reference guide p CO q U C t S Date April 06 2011 3 Contents of the packaging VascuLuminator stand VascuLuminator arm with monitor and camera Battery charger model VascuLuminator 330 00 Power cable EU 220V 50Hz IR Applicator No410 00 Swivel arm support clamp M6 Bolt Allen wrench 2 pcs 4 mm and 1 5 mm DKMP bv Arnhem NL 21 50 VascuLuminator 3186 GENO5 deHoningn m gt d i C L Reference guide p CO qj U C t S Date April 06 2011 DKMS bv Reference guide 4 Explanation of packaging en product symbols 4 1 Explanation of packaging en product symbols Conformit Europ nne European Conformity This symbol means that the device fully complies with MDD directive 93 42 EEC Notified Body 0344 KEMA Do not dispose of this product in the unsorted waste stream Dispose of this product according to local regulations Consult instructions for use Manufacturer Keep package straight up during transportation This side up Keep dry Date of manufacturing month Year Package contains
31. pter 12 Troubleshooting item 1a and 1b The VascuLuminator is designed for a service life of 5 years The performance of the batteries however may decline during the lifetime depending on the number and time of the charging cycles The batteries are replacement parts and if necessary they can be replaced by qualified service personnel 12 TROUBLESHOOTING Fai Posse talwe cause Actions allowed for the user 1a VascuLuminator does not Charger is not connected Connect charger and push start button start up and start button and batteries are empty again Charge the batteries over gt 8 hours does not light up green or Molex connector at stand Place the binder on the swivel arm yellow after pushing the connection was not Disassemble the arm Reconnect the start button connected after assembly Molex connector between the stand wires of the VascuLuminator and the swivel arm wires and assemble the arm The actions below are only allowed for service personal DKMP bv Arnhem NL 37 50 VascuLuminator 3186 GENO5 deHoningn m gt d i C L Reference guide p O qj LU C t GS Date April 06 2011 Molex connector on Reconnect the Molex connector between footplate wires not the stand wires and the swivel arm wires reconnected after replacing batteries Fuse 1 5 A blown Replace 1 5 A fuse and check functioning of the VascuLuminator If the fuse blows again the VascuLuminator should be investigated by the manufact
32. r frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE Ur is the a c mains voltage prior to application of the test level Portable and mobile RF communications equipment should not be used no closer to any part of the VascuLuminator including cables than the DKMP bv Arnhem NL 13 50 VascuLuminator 3186 GENO5 deHoningn m gt d i C L Reference guide p O cd LJ C t Date April 06 2011 Guidance and manufacture s declaration electromagnetic immunity The VascuLuminator is intended to use in de electromagnetic environment specified below The customer or the user of the VascuLuminator should assure that it is used in such an environment Immunity test IEC60601 test Compliance level Electromagnetic environment guidance level recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 2VP d 1 2VP 80 MHz to 800 MHz d 2 3VP 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Conducted RF IEC61000 4 6 3 Vrms Field strengths from fixed RF transmitters as 150 KHZ to 80 determined by an electromagnetic site survey MHz should be less than the compliance level in each Radiated RF fr
33. tenance free 2 pcs DKMS bv charger type 330 00 100 240Vac 50 60Hz Fast charge 14 7 V Trickle charge 13 8 V 2 x 6A 250Vac 125Vdc fast blow on each battery connection Littelfuse 0314006 MXP 1 x 1 5 A 250Vac 125Vdc fast blow on DC power line Littelfuse 032601 5MXP IP 20 De Koningh Medical Systems type 410 00 6 50 VascuLuminator 3186 GENO5 deHoningn m gt d i C L Reference guide p CO cd U C t S Date April 06 2011 These parts can be ordered as a spare part at DKMP bv DKMP bv Arnhem NL 7 50 deHoningn m gt d i C al Reference guide Version 7 0 By R Stemerdink p CO qj U C t S Date April 06 2011 1 2 Isolation from supply means The VascuLuminator battery charger is coupled to the mains using a flexible power cord with connector The power cord must be disconnected from the mains before service actions are carried out 1 3 Operation mode The VascuLuminator is built for continuous operation The VascuLuminator can be used for at least 10 hrs based on fully charged batteries at the beginning of use The batteries need to be recharged for at least 8 hours after this time by connecting the charger to the mains supply 1 4 Applied parts The applied part in the VascuLuminator the only part that contacts the patient is the infrared applicator This part is a type BF applied part according to IEC 60601 1 This part is made of inert plastic materials which are safe for the p
34. uch an environment Emissions Test Compliance Electromagnetic environment guidance RF emissions Group 1 The VascuLuminator uses RF energy only for its internal function Therefore its RF emissions are very CISPR 11 low and are not likely to cause any interference in nearby electronic equipment RF emissions Class A The VascuLuminator is suitable for use in all establishments other than domestic and may be used CISPR 11 in domestic establishments and those directly i Serene emer E Class A connected to the public low voltage power supply network that supplies buildings used for domestic IEC 61000 3 2 so provided the following warning is needed Warning This equipment system is intended for use Voltage fluctuations flicker Complies by healthcare professionals only emissions This equipment system may cause radio interference or may disrupt the operation of nearby equipment IEC 61000 3 3 It may be necessary to take mitigation measures such as re orienting or relocating the VascuLuminator or shielding the location DKMP bv Arnhem NL 12 50 deHoningn medical products VascuLuminator 3186 GENO5 Version 7 0 By R Stemerdink Reference guide Date April 06 2011 Guidance and manufacture s declaration electromagnetic immunity The VascuLuminator is intended to use in de electromagnetic environment specified below The customer or the user of the VascuLuminator should assure that it is used in such an en
35. urer VascuLuminator batteries Batteries are worn out Replace both batteries run empty fast lt 8 hours after being charged One battery fuse is blown Check the 6 A battery fuses and replace if completely gt 8 hours necessary Check the functioning of the VascuLuminator If a fuse blows again replace the corresponding battery Batteries are not fully Batteries are worn out Replace both batteries charged after more than 8 hours of charging Charger malfunction Check charger connector on foot plate No or only little infrared light Fiber cable is completely Replace the complete IR applicator is emitted from the IR of partially broken applicator Infrared led does not Remove the fiber from the connector work Observe if the IR led is emitting red light is visible inside the connector If the IR led is broken contact the manufacturer for repair Fiber cable is not Turn the set screws anticlockwise and completely pushed into puns the fiber into the fiber bush as far as the fiber connection bush possible Tighten the set screws again on the suspension arm If the scheme above is followed but does not lead to improvement the VascuLuminator should be investigated by the manufacturer DKMP bv Arnhem NL 38 50 VascuLuminator 3186 GENO5 deHoningn m gt d i C L Reference guide p CO qj U C t S Date April 06 2011 13 Disposal Do not dispose of this product in the unsorted waste stream Dispose o
36. vironment Immunity test IEC60601 test Compliance level Electromagnetic environment guidance level Electromagnetic discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 1 1 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 6 kV contact 8 kV air 2 kV for power supply lines 1kV for input output lines 1 kV differential mode 2 kV common mode lt 5 Ur gt 95 dip in Ur for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip in Ur for 25 cycles lt 5 Ur gt 95 dip in U for 5 sec 6 kV contact 8 kV air 2 kV for power supply lines 1kV for input output lines 1 kV differential mode 2 kV common mode lt 5 Ur gt 95 dip in Ur for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip in U for 25 cycles lt 5 Ur gt 95 dip in Ur for 5 sec Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Powe
Download Pdf Manuals
Related Search