IntraSkan DC User Manual - at www.ImageWorksCorporation.com.
Contents
1. MAX TUBE KV 70 kV DC MAX CURRENT 8 mA BASE UNIT MAX X RAY ON TIME 4 s Duty 1 15 PART No REF TOTAL FILTRATION 22 5mm AL 70kV SERIAL No SN FOCAL SPOT SIZE m0 5 IEC 60336 lt 60mm DATE mi X RAV BEAM SIZE 85 220mm X RAV TUBE MODEL NO REF OX 70 5 Illustration 12 Base Unit SI No Label 410 TUBEMFG BV ONA Illustration 13 Tube Housing label for focal sport 0 5 412 TUBE HOUSING PART No REF SCISSOR ARM SERIAL No SN PART No IREF MEG DATE SERIAL No SN TUBE SERIAL NO SN MFG DATE M Illustration 14 Tube Housing SI No Label 13 Illustration 15 Scissor Arm Label 14 EXTENSION CONE PART No E SSD Illustration 16 L Arm Dome Label 16 Illustration 17 Extension Cone Label Optional 17 CASTED BASE BASE COLUMN g No REF PART No Illustration 18 Base Column Label 418 Illustration 19 Casted Base Label 19 13 CHAPTER 3 KNOW YOUR INTRASKAN DC AS Behind Tubehead Inside Base Unit Bo 06 Figure 2 Intraskan DC System Label Location Refer section 3 2 Page 12 for System Labels 3 3 Int2. Interaction with Sales Service Team Fully Satisfied LI Satisfied L Unsatisfied Product Condition when received Fully Satisfied LI Satisfied LI Unsatisfied Technical details for product Installation Fully Satisfied Satisfied Unsatisfied Technical details for product Operation Fully Satisfied LI Satisfied Unsatisfied Product meets Intended use amp performance Fully Satisfied LI Satisfied LI Unsatisfied Technical details for product maintenance Fully Satisfied LI Satisfied LI Unsatisfied Response from service team Fully Satisfied LI Satisfied L Unsatisfied Quality of service Fully Satisfied LI Satisfied LI Unsatisfied Notes if any D Receipt of feedback Receiver Name Signature Date Feedback by Phone e mail web site Physical copy Others Specify Contact Address ImageWorks 250 Clearbrook Road Suite 240 Elmsford NY 10523 Phone 1 914 592 6100 Fax 1 914 592 6148 Title ImageWorks Customer Feedback Form Page 2 of 2 Instruction for filling up format About this format It is used for obtaining feedback from customers on products and process that are supplied by ImageWorks A Feedback by Customer Name address contacts number These are details of customer who provides feedback on products they have purchased from ImageWorks or its subsidiaries or its Authorised dealers
3. Figure 9 Floor Mount Intraskan DC Sweep Figure 10 Floor Mount Intraskan DC Extended Figure 11 Floor Mount Intraskan DC Top View mem Figure 12 Floor Mount Intraskan DC Storage Dimensions Figure 13 Intraskan DC Keypad Console and Wall Mounting Configurations Figure 14 Intraskan DC Keypad Console with LED Figure 15 Doorbell diie EE OE RR EE EE AE EE AE Figure 16 Remote Keypad Console is ER Re De Lee amenas ER He pr a Lee ta rt Figure 17 2 EE OE eL ge EE RE RE Pet iae EE Figure 18 Parallelirig Techrnlque icio iret et Lee tated cots ee ete Ec EE e eee EB Ee rett Figure 19 Home Screen ii dise OE EE EE tu Figure 20 Home Screen with S Highlighted rear ens Figure 21 mA parameter modified and accepted ii ee RA AE ee GR ee RA Re ee ee ee ee ee ee ee ent Figure 22 EE eie ME e AA Figure 23 X Ray EXPOSING a aa Figure 24 X Rav Results N Figure 25 Startup Screerz s RE o tA ta Figure 26 Home SCreen i i oct A dI Figure 27 Mode Selection Screen una capri ee e C a de eee tnde Figure 28 Automatic mode i se tto pete tv a pk col a Figure 29 Manual mode ert Hey E d ifr Dads ta e dep RO Figure 30 Config
4. Ka 205mm 8 Figure 7 Wall Mounted Intraskan DC Vertically Extended 16 CHAPTER 3 KNOW YOUR INTRASKAN DC 1795mm 71 Figure 8 Floor Mount Intraskan DC Fully Extended Dimensions y 35 to 40 Figure 9 Floor Mount Intraskan DC Sweep Angle 17 CHAPTER 3 KNOW YOUR INTRASKAN DC 1219mm 48 935mm 37 Figure 10 Floor Mount Intraskan DC Extended Dimensions 992mm 39 Figure 11 Floor Mount Intraskan DC Top view CHAPTER 3 KNOW YOUR INTRASKAN DC 1956mm 77 140mm 5 5 1143mm 45 965mm 38 711mm 28 940mm 37 914mm 36 View A Right Side View View B Front View Figure 12 Floor Mount Intraskan DC Storage Dimensions CHAPTER 3 KNOW YOUR INTRASKAN DC 3 4 Intraskan DC Wall mount Configurations Figure 13 Intraskan DC Keypad Console and Wall mounting Configurations Configuration 1 EF Note For Configurations 2 7 1 RJ45 8P8C 35 Cable CAT 5 24AWG 4 Iwisted Pair 1 1 Connection Similar to BELDEN P N 1624R 2 RJ11 6P4C 35 Cable Center 4 Positions Populated 1 1 Connection Similar to P N ES 2521 B 3 3Wire 35 Cable Shielded or Un shielded Cable AWG 20 28 P N LAPP0028503 4 2 Wire shielded or unshielded cable AWG 20 28 P N LAPP0028502 Building Power Box Internal Wiring Mains power cord Base Unit Can use Internal Keypad Console and Internal E
5. 4 2 Positioningithe Patient cs cas ii ri netu mn mtt 26 4 3 Achieving the Best Image Quality errei 27 44 Power Turn On Procedure ee ke AA Ee ee EE GR AR AA ee ee ee ee ee aaa aaa Re ee ee ee ee ee ea ee 28 4 5 Intraskan DC Operating Procedure Summary iese esse ee ee ee RR ee ee ee Re enne 29 4 6 Exposure Settings and AE lo SE in det RE RE N EE OE ER 29 4 6 1 Default Exposure Program Presets eed de ee ke ee de ee ee eem nennen ee de 29 4 6 2 Default Exposure Values nr ee ee AR Ee Re ee ee ee ee ee ee ee ent 29 4 7 Delivering an Exposure Procedure ssa etit e re Heg ee 29 Chapter 5 Using the Keypad Console sss nennen eere nennen nnns 34 5 1 Selecting a Preset Mode eon ria Ed ma etie est a dtd d diede 34 5 2 Selecutg KWe i RE Em A ARE OE MALI LO EIE 34 5 3 Configuring Defaults Ee SE See ee ua dio mild eae 35 5 4 Console Events itu edsane ha ol te OE EO ta 36 Chapter 6 Maintenance sapata ue eed L a a 37 6 1 Cleaning and Disinfecting us eee d sta da et ten tercie Hon re e eei ur Re E 37 6 2 Caring For Your Equipment ete e tod a an i RM 37 6 3 Shipping Long Term Storage and Tube Seasoning a 38 6 4 Preventive Maintenance isdie eoe 38 6 5 Disposal ofthe Unit A OE ED OE N AE ee ce 38 Chapter 7 Troubleshooting an
6. ERROR Home After an internal error that requires user lt error code gt service intervention Please restart 36 GHAPTER MAINTENANCE 6 1 Cleaning and Disinfecting Important Turn OFF Intraskan DC Wall mount or turn OFF and unplug the Intraskan DC Floor Mount Unit Wait for 2 minutes before proceeding with service Active internal circuits remain connected to main voltage even when main power switch is turned off Use a soft damp cloth to clean the outside surfaces of the equipment Do not spray or let the cleaning fluid enter the unit Periodic disinfecting of the unit is required for hygiene Disinfect with a compatible low or intermediate level instrument grade disinfectant after cleaning Use a non acetone based disinfectant liquid Cleaning Methods In order to ensure proper hygiene especially when protective barriers are not used between each patient clean and disinfect Intraskan DC by thoroughly performing the following procedures Important Make sure that the unit is completely dry before plugging in or tuming power back on Exterior Surfaces Wipe the outside surfaces with a disposable towel moistened with water Dry the external surface with disposable towels Parts in Contact with the Patient s Skin To ensure proper cleaning of these parts periodic disinfection with an approved EPA Non Corrosive Surface Disinfectant is recommended Clean any remaining disinfectant residue from the system with a di
7. INTRASHAN DC High Frequency IntraOral X Ray System User s Manual TABLE OF CONTENTS Chapter 1 Safety and Precautions eene nennen eren 7 1 1 General Safety Tips ini e dace e ed De ach a iai ru e d Due ide vd 7 1 2 Safety Symbols EE EE EDE ER EE meti tei etate reet 8 Chapter 2 Introduction EE ER rette tte ono mtr EDI p a a SR Ra Ee 9 2 1 Intraskan DE X Ray Equiptrent i eiie IIR ev ede tarde chat 9 2 2 Indication for USE t t age 9 2 3 ThisiManuals 3 d 9 2 4 Included System Components ie ee ee ee Re ee Ge RR ee RA nn ee RR ee ee ee ee 10 Chapter 3 Know Your Intraskan vann ee ee 11 3 1 Key Components Identification nn nr EEE nr ee ee ee nt 11 3 2 eN EE ER RE EE N EE 12 3 3 Intraskan DC Reach Dimensions and Movements ii sss 14 3 4 Intraskan DC Wall mount Configurations ke ee ee ee ER ee 20 3 5 Keypad Console ae a ep Ge eee be deed ee ee de 24 9 5 1 Graphical CD Display ke 24 3 95 25 Insee EE mea 24 Chapter 4 Operating Intraskan DE de oe ER e HR NER AM Gl 26 4 1 Before YoU Begin 222 ee ee eet e EE 26
8. Senders name cell phone and e mail address These details are of a person who actually provides the feedback B Product Details Product Full System type model Serial number These are product full system identification numbers mentioned in rating plate label Product application Actual usage purpose of products for performing various functions examples Radiography Fluoroscopy etc Installed site Address Equipment installed location organization contact person and phone numbers details if installed site is not same as organization details given A Ifitis same write as Same as A C Feedback Check respective check boxes for each feedback points Feed back can be sent after actual usage of more than 6 months Notes This field is for recording any relevant information provided by the customer D Receipt of feedback Complaint All details are self explanatory Contact Address ImageWorks 250 Clearbrook Road Suite 240 Elmsford NY 10523 Phone 1 914 592 6100 Fax 1 914 592 6148 ImageWorks Generations of Imaging Corporate Headquarters 250 Clearbrook Road Suite 240 Elmsford NY 10523 USA Phone 914 592 6100 Fax 914 592 6148 www imageworkscorporation com O ImageWorks Copyright 2013 P N 515 001597 0 Rev B Sept 2013
9. 0 0398 0 04 0 04 x 100 0 005 x 100 0 5 Each measured value is verified with rejection limit 8 0 04 0 40 2 4 Rejection limit set 10 of set exposure time NLA 8 2 Indirect Measurement method Model Remarks 9096 Any Equivalent equipment can be used 02 40x 12 W with valid calibration Test Procedure Place the kVp sensor at 25cm from the focal spot Visually center the kVp probe in the x rav beam path such that the beam will strike sensor in the probe as shown in the picture below Once aligned deliver an exposure protocol 70kV 8mA 0 045 and capture the wave form in the oscilloscope ti Acceptance criteria No over shoot in the kV waveform kVp Sensor Figure 37 kV measurement using kVp sensor 43 ANNEX TECHNICAL SPECIFICATIONS Table A1 Tube head Specifications Description Specification Generator Type High Frequency Microprocessor Controlled Constant Potential DC Control of High Voltage Closed Loop High Voltage Range 55kV 7OKV Settable Step size 1kV Accuracy of High Voltage lt 5 High Voltage Ripple Frequency gt 200kHz High Voltage Ripple Low Frequency Ripple lt 10kHz shall be less than 2 p to measured 70kV 8mA High Frequency Ripple lt 50kHz shall be less than 10 p to measured 70kV 8mA High Voltage Rise Time lt 3ms Control of Tube Curre
10. 6 Danger Label 5 12 B ImageWorks X RAY CONTROL CONSOLE 309 000034 0 mac _ elf Illustration 5 X Ray Control Console Label 4 CAUTION X RAYS ATTENTION RAYONS X Illustration 7 X Rays Caution Label 6 Manufactured For ImageWorks B ImageWorks 250 Clearbrook Road Suite 240 Elmsford Manufactured by NY 10523 USA Skanray Technologies Pvt Ltd S Plot No 15 17 Distributed by Hebbal Industrial Area ImageWorks Mysore INDIA 570016 Illustration 8 Manufacturer Label 47 High Frequency Intra Oral X Ra PART No B ImageWorks REF SERIAL No SN MFG DATE Illustration 9 System Label 8 GHAPTER 3 f REZA MEDICAL APPLIED ELECTROMAGNETIC U RADIATION EQUIPMENT CXS L US AS ELECTRICAL SHOCK FIRE AND 3029 MECHANICAL HAZARD ONLY IN ACCORDANCE KNOW YOUR INTRASKAN DC BASE UNIT B ImageWorks INPUT VOLTAGE 1 Phase 110V INPUT FREQUENCY 60 Hz WITH ANSI AAMI ES60601 1 2005 C1 09 A2 10 IEC 60601 1 2005 CORR 1 MOMENTARY CURRENT 8 A MAX 2006 CORR 2 2007 CANICSA C22 2 No 60601 1 2008 IEC 60601 1 3 2008 IEC STANDBY CURRENT 0 25 60601 2 65 2012 IEC 60601 2 28 2010 Illustration 10 3rd Ed UL Mark Label 9 N Illustration 11 Base Unit Label 11 TUBE HOUSING lmageworks
11. 61000 4 6 50 kHz to 80 MHz 150 kHz to 80 MHZ be used no closer to any part of the Imageworks High Frequency Intraoral X Ray including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 2 d 1 2 VP 80 MHz to 800 MHz d 2 3 VP 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 Radiated RF 3 V m 3 V m Field strengths from fixed RF transmitters as EN 61000 4 3 80 MHz to 2 5 GHz 80 MHz to 2 5 GHz determined by an electromagnetic site survey a should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol 29 At 80 MHz and 800 MHz the higher frequency range applies These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflec tion 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 measu
12. 8 0 14 0 44 0 11 0 35 Adult Molar 70 8 0 16 0 49 0 13 0 39 70 8 0 14 0 44 0 11 0 35 Bitewing 70 8 0 07 0 19 0 05 0 13 Canine 70 8 0 1 0 31 0 08 0 22 Child Molar 70 8 0 12 0 34 0 09 0 24 70 8 0 1 0 31 0 08 0 22 Table 2 Default Exposure Values for Short Long Cone R2 Custom Estimated Exposure Values kV mA amp S mentioned below are for minimum patient dose and can be modified as per user requirement Time S Anatomy kV mA Cone Short Long Bitewing 70 8 0 07 0 22 Canine 70 8 0 11 0 35 Adult Molar 70 8 0 13 0 39 Pre Molar 70 8 0 11 0 35 Bitewing 70 8 0 05 0 13 Canine 70 8 0 08 0 22 Child Molar 70 8 0 09 0 24 Pre Molar 70 8 0 08 0 22 32 CHAPTER 4 OPERATING INTRASKAN DC Table 3 Default Exposure Values for Short Cone R3 Custom Estimated Exposure Values kV mA amp S mentioned below are for minimum patient dose and can be modified as per user requirement Time S Anatomy kV mA Cone Short Bitewing 70 8 0 15 Canine 70 8 0 13 Adult Molar 70 8 0 15 Pre Molar 70 8 0 13 Bitewing 70 8 0 11 Canine 70 8 0 11 Child Molar 70 8 0 12 Pre Molar 70 8 0 11 Table 4 Default Exposure Values for Long Cone R3 Custom Estimated Exposure Values kV mA amp S mentioned below are for minimum patient dose and can be modified as per
13. Frequency Intraoral X Ray is to be used as a source of X Rays in Dental radiography Only trained professionals should use this device Federal law prohibits the sale of this device to individuals other than trained professionals Use of this device other than as described in this manual may result in injury 2 3 This Manual This manual is not to be used as a replacement for training in radiography The document contains basic operation instructions identification of parts system labels and safety guidelines for the Intraskan DC models listed below Additionally troubleshooting tips are provided should the equipment not perform as intended The following are guidelines for using this manual Alerts users to important instructions that require caution when operating the unit since they are related to safety This symbol points to an important detail tip in the operation of the unit Read carefully to avoid any problems This manual describes the user interface of the keypad Console using images as shown to the left These images are indicative only and the values displayed may differ from the actual values unless specified otherwise CHAPTER 2 INTRODUCTION 2 4 Included System Components The Wall Mounted Intraskan DC system is available in three model configurations using different Straight Arm assembly Top Level Variants Intraskan DC Intraoral X Ray Floor Mount Wall Mounted Intraskan DC High Frequency Intraoral X
14. Ray with 15 Straight Arm Wall Mounted Intraskan DC High Frequency Intraoral X Ray with 24 Straight Arm Wall Mounted Intraskan DC High Frequency Intraoral X Ray with 33 Straight Arm Unpack each component and verify that items listed below are received as appropriate If any item is miss ing or damaged notify your authorized dealer Description Part No Wall Mounted 15 Straight Arm without remote switch 9992720300 Wall Mounted 24 Straight Arm without remote switch 9992720200 Intraskan DC High Fre Wall Mounted 33 Straight Arm without remote switch 9992720000 quency Intraoral X Ray Wall Mounted 15 Straight Arm with remote switch 9992720350 only Wall Mounted 24 Straight Arm with remote switch 9992720250 Wall Mounted 33 Straight Arm with remote switch 9992720050 Floor Mount 9992720100 Contents Note The Tube head is shipped attached to the Scissor Arm 15 Long SK 309 000422 0 re eno EE 50300001230 33 Long SK 309 000424 0 Scissor Arm Assembly includes cables SK 309 000425 0 70kVp 8mA Tube head Assembly SK 309 000426 0 Base Unit Assembly SK 309 000427 0 Exposure Switch with Cable SK 309 000428 0 Template for Wall Plate Single Stud Mounting Installations SK 207 001473 0 Intraskan DC Extension Cone SK 211 000317 0 16 Wall Plate with template Optional 9992720002 Remote Keypad Console with template Optional 9992720003 Doorbell Switch with
15. color and the LED D6 green color on test control board should be blinking every 1 sec approx Indication on Console board Note Do not press any key when console displays the message SELF TEST All LED s should glow during self test amp LCD will display all 3 Red Green amp Blue colours in sequence Console should boot into the home screen without displaying any error message 3 Command exposures through operator console with kV mA and S settings shown in table below Press amp hold exposure button till exposure done signal comes in the LCD display Measure and Record the voltage on Oscilloscope Tube poten tial signal measured from DSO are multiplied by Design factor 80 6 Each measured tube potential is verified with rejection limit 4 CHAPTER 8 MEASUREMENT TECHNIQUES Tube kV Tube Current Exposure Time 55 60 65 70 4mA 0 045 4mA 4s mA 0 04s mA 4s 8 0 045 4 Rejection limit Design 3 To be measured by a DSO having accuracy lt 42 Difference between kV Command to kV actual shall be lt 5 Tube Current testing method Tube current measurement is direct method by using shunt Sensing resistor 750Ohms 1 and DSO as shown be low Current sensing circuit is inbuilt into the INTRA SKAN DC and measurement point TP5 provided for hooking measur ing probe 750R 750R Ue Feedback gt gt gt TO DSO mA Feedback 1V 1 33mA from Tank 6V 8mA 4 7n 4 7n Figure 35 mA Fee
16. the equipment as they may cause short circuit and or corrosion Mechanical Safety Where complete safeguarding of the equipment is not possible due care must be taken to ensure that no part of the user s or patient s body or clothing can be trapped or injured by any part of the equipment In particular make sure that fingers are not caught or pinched during scissor arm movement Electromagnetic This equipment complies with EMI regulations Interference between the unit and other Interference sensitive electronics can occur under extreme conditions Do not use the X Ray equipment in close conjunction with other sensitive devices or devices which create high electromagnetic disturbance Physical Injury Exercise caution when operating the mechanical scissor arm Since the arm mechanism allows free movement with minimal force a swinging arm can inadvertently cause injuries The swinging joints on the arm are potential pinch points Use caution while operating the arm Installation and Installation and service of Intraskan DC must only be done by an authorized service engi Service neer Consult the factory or dealer as necessary Make sure that Intraskan DC is assembled and installed in compliance with all applicable laws and recommendations concerning electrical safety Explosion Safety This equipment must not be used in the presence of flammable or potentially explosive disinfecting gases or vapors which could ignite causing personal injury
17. HOCK FIRE AND 3UZ9 MECHANICAL HAZARD ONLY IN ACCORDANCE WITH ANSI AAMI ES60601 1 2005 C1 09 A2 10 IEC 60601 1 2005 CORR 1 2006 CORR 2 2007 CAN CSA C22 2 No 60601 1 2008 IEC 60601 1 3 2008 IEC 60601 2 65 2012 IEC 60601 2 28 2010 B4 Declaration The products described herein are designed manufactured inspected tested and released by Skanray Technologies Pvt Ltd a contract manufacturer for ImageWorks Inc in accordance with FDA s 21CFR Part 820 ISO 9001 2008 UL File A17728 and ISO 13485 2003 UL File A17728 B5 Authorized Representative ImageWorks 250 Clearbrook Road Suite 240 Elmsford NY 10523 USA 1 914 592 6100 Voice 1 800 592 6666 Toll Free 1 914 592 6148 Fax Web www imageworkscorporation com 48 ANNEX C GUIDANCE amp MANUFACTURER S DECLARATION According to EN 60601 1 2 2001 A1 2006 Group 1 class A for use in Hospitals Not LIFE SUPPORTING ImageWorks High Frequency Intraoral X Ray is tested per applicable IEC standards to be used under electromagnetic environment specified below The customer or the user of ImageWorks High Fre quency Intraoral X Ray should assure that it is used in such an environment Table C1 Guidance and Manufacturer s Declaration Electromagnetic Emissions For all EQUIPMENT and SYSTEMS Electromagnetic Emissions Test Compliance Environment sGulde ImageWorks High Frequency Intraoral X Ray uses RF RF emissions EN 55011 energy
18. Mobile Support Platform provides a stable portable operating base for Intraskan DC Floor Mount Tube head with Beam Limiting Device Both Wall mount and Floor Mount Units Provides 55 kV 70 kV voltage range adjustable in 1 kV steps and 4 mA 8 mA current range adjustable in 1 mA steps to reduce exposure times and the amount of radiation absorbed by the patient The tube head is equipped with a beam limiting device with a 220mm source to skin distance and 60mm beam diam eter at the output The tube head is connected to the arm by means of a rotating contact allowing 540 degree horizontal rotation and 310 degree vertical rotation C 2 AENA Scissor Arm m d c Assembly Horizontal Arm Part of Scissor Arm Assembly Vertical Arm Ed Pa of Scissor fl Arm Assembly Arm Assembly Lue Tube Head Shipped attached to Scissor Arm Assembly Position Indicating Device PID or Cone Tube Head Shipped attached CJ to Scissor Arm Assembiv Straight Arm choice of long and short Position Indicating Device PID or Cone Exposure 2 l Switch A poc Mains Power E ON OFF Switch Remote Keypad Console Door bell Switch Keypad Console Mains Power ON OFF Switch Mains Power Line Cord Rear Mobile Support Platform Z S BO 08 Wall Mounted Intr
19. TING CURVE WITH 35 Watt DISSIPATION kJ mins Figure A 3 Heating and Cooling Curve Table A3 Mechanical Dimensions and Weight Comment Value Description Total Weight of System including Packing Carton Weight of Tube head Straight Arm Material Type of painting Mounting type Extended Arm Reach Height of unit with Arms folded Wall Mount Height of unit with Arms folded Floor Mount Straight Arm Rotation about Base Scissor Arm Swing Wall Mount Scissor Arm Swing Floor Mount Tube head swivel on horizontal plane Tube head rotation about Vertical Plane Wall Mount 15 Straight Arm 86 Ibs 24 Straight Arm 90 Ibs 33 Straight Arm 95 Ibs Floor Mount 223 Ibs 11 023 Ibs Approx Aluminum Glossy Base Unit adapters for Wall mounted or Floor Mount 15 Straight Arm 61 24 Straight Arm 71 33 Straight Arm 80 49 0 5 77 X 0 5 160 10 205 5 46 ANNEX A TECHNICAL SPECIFICATIONS Table A4 Mains Power Requirements Line voltage range 110 VAC 10 Range of line voltage regulation for 1 maximum at 99 VAC 60Hz operation at maximum line current Line frequency Nominal 60 Hz Range 54Hz to 66Hz Momentary Current 70kV 8mA 8 110 Momentary Power 70kV 8mA 0 88 kVA 110 Standby Current 250mA maximum Line resistance lt 0 4 Ohm Current Peak 30 A for 2 ms at mains turn on Input Power Factor 20 9 during any exposure Electric
20. al Classification Class Type B Line Neutral and Ground 1 Phase Electrical Connection Ground is Mandatory Table A5 Environmental Conditions Operating conditions Temperature 50 F to 104 F Humidity 25 to 75 Altitude 1500m Conditions for transport and storage Temperature 22 F to 158 F Humidity 95 non condensing Altitude 3500m 47 ANNEX B DECLARATION OF CONFORMITY B1 Name and Description of Product Medical device name ImageWorks High Frequency Intraoral X Ray Medical device model ImageWorks High Frequency Intraoral X Ray Device Variants 303 000133 X ImageWorks High Frequency Intraoral X Ray with Focal Spot Size 0 5 in a Wall Mount configurations using a Straight Arm Where X 15 24 and 33 303 000133 8 ImageWorks High Frequency Intraoral X Ray with Focal Spot Size 0 5 in a Floor Mount configuration Medical device Type Dental X Ray System Medical device classification Ilb Rule 10 MDD Class Il FDA B2 Standards under which conformity is declared ANSI AAMI ES60601 1 2005 C1 09 A2 10 IEC 60601 1 2005 CORR 1 2006 CORR 2 2007 CAN CSA C22 2 No 60601 1 2008 IEC 60601 1 2 2006 IEC 60601 1 3 2008 IEC 60601 2 65 2012 IEC 60601 2 28 2010 21 CFR Subchapter J CMDR SOR 98 282 B3 Marking The products described herein conform to the UL safety marking MEDICAL APPLIED 9 ELECTROMAGNETIC U RADIATION EQUIPMENT CXS L US AS ELECTRICAL S
21. alues of S to be altered select bv pressing S mA until the pa rameter is Highlighed and change using Up amp Down kevs EH Figure 20 Home Screen with S Modifv th t highlighted EE Press UP DOWN keys the required number of times to change the highlighted parameter The parameter being changed to indicate the operation Accept the change The set parameters are accepted automatically Figure 21 mA parameter modified and accepted 30 Preparing Press amp hold EXP key Figure 22 X Ray Preparing Figure 23 X Ray Exposing WAIT kV 59 9 mA 7 99 S 0 11 Figure 24 X Ray Results CHAPTER 4 OPERATING INTRASKAN DC Now press Exposure Switch or Remote Exposure Button on the Doorbell switch to initiate the exposure Here the unit prepares itself to deliver the exposure This stage might take a few seconds Verify that an audible beep occurs and the X Ray status indication LED illuminates green Stop or abort an exposure by simply pressing any key other than the Exposure Switch IF The Exposure Switch must be kept depressed throughout the entire exposure Releasing the Exposure Switch before the end of the exposure terminates the emission with the message displaying X RAY ABORTED Verify that an audible beep occurs and the screen shows the radia tion icon while the exposure is being delivered The X Ray status indication LED also illuminates
22. and or damage to the equipment If such disinfectants are used the vapor must be allowed to disperse before using the equipment This equipment is not suitable for use in presence of anaesthetic gases 7 CHAPTER 1 SAFETY AND PRECAUTIONS Floor Mount Care must be taken for the movement and positioning of Intraskan DC Floor Mount The Floor Mount system is meant for limited movement inside the clinic and is not suitable for Transport applications Before moving the Floor Mount system around the scissor arms must be folded to avoid unnecessary damage to the system The wheel locks should be unlocked before moving the system After the system is placed at the desired location the wheel locks should be put in lock position This equipment is meant for limited movement within a clinic or hospital room Adequate care should be taken while moving on ramp or on an uneven surface 1 2 Safety Symbols The following safety related symbols are found on the equipment Caution Symbol This symbol indicates the user to be cautious and refer to the user manual for safe operating instructions Protective Earth Ground Mains Earth Ground is required for continued protection against shock hazards Type of Insulation Class 1 Type B Insulation Protection against electric shock UL60601 1 2003 Requires protective Earth Connection High Voltage Dangerous voltages present Caution X Ray X Ray Sou
23. askan DC Intraskan DC Floor Mount Figure 1 Intraskan DC Key Component Identification 11 CHAPTER 3 KNOW YOUR INTRASKAN DC 3 2 System Labels This section shows the required system labels that are affixed on the unit Refer to Figure 2 for the location of each label by the corresponding item number below the label STRAIGHT ARM XX RT No Complies with FDA Radiation Performance Standards 21 CFR Subchapter J Illustration 1 Straight Arm Label 1 Illustration 2 FDA Label 42 1 H t o 9 B A o gt w io e in gt i D 9 E in in s a u amp 3 q e q EA 3 d 5 3 batch Doc o Hibubululbululululululi Illustration 3 Angular Tape 15 WARNING X RAYS MAY BE DANGEROUS TO THE PATIENT AND THE OPERATOR UNLESS SAFE EXPOSURE FACTORS OPERATING INSTRUCTIONS AND MAINTENANCE SCHEDULES ARE OBSERVED PROPER GROUNDING IS MANDATORY FOR THIS EQUIPMENT X RAYS AN TO BE OPERATED BY AUTHORIZED PERSONEL ONLY AN HIGH VOLTAGE NO RECYCLE INTO NORMAL TRASH Ri FOLLOW INSTRUCTIONS FOR USE V Illustration 4 Warning Label 3 Hazardous Voltage TO REDUCE THE RISK OF ELECTRIC SHOCK DO NOT REMOVE COVERS OR CABLE UNTIL 5 MINUTES HAVE ELAPSED AFTER TURNING OFF THE EQUIPMENT FAILURE TO COMPLY MAY CAUSE SEVERE INJURY OR DEATH A Illustration
24. ch is described on the following page 3 5 1 Graphical LCD Display The LCD display on the keypad Console offers a rich user interface displaying the selected exposure parameters along with many other user friendly features The screen components of the home screen are shown by Figure 14 3 5 2 Keypad In addition to the LCD display the keypad Console contains 8 keys and exposure LED indicator These keys are used to select the exposure parameters Intraskan DC simplifies the process of selecting exposure parameters using pre programmed settings for every combination of image receptor adult child and tooth anatomy as described by section 4 7 Selecting an Exposure set of this manual Additionally an audible signal beep sounds to confirm keypad button selection and when certain errors occur This alert is also heard during any X ray emission occurrence Selected exposure duration in seconds Status Indication LED UP Increment Key Canine Incisor DOWN Decrement Key Bitewing Seconds Milliampere Adult Child Select Figure 14 Intraskan DC Keypad Console with LCD Display Figure 15 Door Bell switch Figure 16 Remote keypad Console 24 GHAPTER 3 KNOW YOUR Table Key description INTRASKAN DC Exposure Status LED Indicator No Color Idle Standby Green Ready to Deliver X Ray Orange Exposure in Progress Red Operation Fault UP DOWN Keys Navigate up down a list me
25. d Error Codes ee ee ee ee ee ee ee ee ee ee Re ee ee mnn ee 40 Chapter 8 Measurement Techniques isi ee ee ee RR AA Re Re Ge ee ee ee ee GR ee AA Re Re ee ee ee ee ener nnne rennes 41 Annex A Technical Specifications 44 Annex Declaration of Conformity Re emen eren ee ee 48 Annex Guidance and Manufacturer s Declaration 49 Annex D Contact Details EE EE ege ret aee ine Re se 52 LIST OF ILLUSTRATIONS Figure 1 Intraskan DC Key Component Identification Figure 2 Intraskan DC Label Location nn emn Figure 3 Wall Mounted Intraskan 15 Support Tube Fully Extended Right Side and Top Views ee ek Re AR Re em emnes Figure 4 Wall Mounted Intraskan DC 24 Support Tube Fully Extended Right Side and Top Views ee ee ee Re ek ee AR Re ee ee memes Figure 5 Wall Mounted Intraskan 33 Support Tube Fully Extended Right Side and Top VIEWS emere Figure 6 Wall mounth Intraskan DC Ground Clearance amp Horizontally Extended Figure 7 Wall mounth Intraskan DC Vertically Figure 8 Floor Mount Intraskan DC Fully Extended Dimensions
26. d back circuit o Test procedure Production test will be performed with nominal input voltage 110Vac 60Hz 1 Connect the probe of the DSO to TP5 mA feedback with respect to ground mounting screw of control board as shown in the Figure 34 2 Switch ON the AC mains Indication on Control board The fault LED D10 on test control board should not glow red The LED D7 on test control board should glow green colour and the LED D6 green colour on test control board should be blinking every 1 sec approx Indication on Console board Note Do not press any key when console displays the message SELF TEST All LED s should glow during self test amp LCD will display all 3 Red Green amp Blue colours in sequence Console should boot into the home screen without displaying any error message 3 Command exposures through operator console with kV mA and S settings shown in table below Press amp hold expo sure button till exposure done signal comes in the LCD display Measure and Record the voltage on Oscilloscope Tube current calculated from DSO signal multiplied by scaling factor of 8 6 Measured Tube current reading are verified with rejection unit Tube current kV S loading mA 55 0 04 70 0 04 4 Rejection limit Design 3 To be measured by a DSO having accuracy lt 2 Difference between mA Command to mA actual shall be 5 Exposure time test method Exposure time measurement is direct method by usi
27. d by the user and the related costs 38 CHAPTER 7 TROUBLESHOOTING amp ERROR CODES Intraskan DC has been designed with safety features to protect the patient and operator in case of failure of an electrical component The system automatically checks for errors and will report a malfunction by means of an error code on the Keypad Console display These error codes are listed in the Table 7 below The table lists the code and identifies the corresponding equipment operational fault The corrective action for the error code is provided by Table 8 which also lists observed problems and their potential source Table 7 Error Codes Deca Communication error Console and tube head are incompatible X Ray preparation time out Anode arc fault Cathode arc fault Over kV fault Over mA fault kV regulation fault Filament open fault Filament limit fault CAN fault Key jam error 39 CHAPTER 7 TROUBLESHOOTING amp ERROR CODES Table 8 provides troubleshooting tips to help the user recover from an equipment fault condition It lists observed problems as well as recommends the corrective actions Table 8 Troubleshooting Tips Observed Problem Recommended Action Error state with display indicating Switch off mains power Wait for 2 minutes and then Switch on mains CNXXX error code power If the problem persists contact authorized service personnel Error state with display
28. ds the tooth to be examined Arrange the tube head with an angle suitable for the required exposure and positioning Move as far away as the Exposure switch cable allows in a direction opposite to the X ray beam emission while maintaining visual contact with the keypad Console and the patient DES Refer to Tables 1 through 4 Page 32 to 33 for estimated exposure values of minimum patient dose that can be modified per user requirement in Custom mode Create an exposure by performing the Exposure Delivery Procedure provided in section 4 7 Make sure to refer to Chapter 5 for details on navigating the keypad Console for setup and operation of Intraskan DC as necessary 4 6 Exposure Settings and Tables 4 6 1 Default Exposure Program Presets By default the keypad console boots into R1 Short cone Adult Canine Incisor Presets The default or start up ex posure program is the exposure program set to operate Intraskan DC upon power turn on of the unit The default exposure program can be changed using the keypad Console by performing the Setting a Preset as the Start up Mode procedure provided in section 5 2 4 6 2 Default Exposure Values Estimated exposure values kV mA amp S listed by Tables 1 through 4 Page 32 to 33 are for minimum patient dose and can be modified per user requirement later Refer to the tables below for Default Exposure Values for specific Intraskan DC application modes and options Table 1 Table 2 Table 3 Tabl
29. e 4 Default Exposure Values for Short Long Cone R1 Film Default Exposure Values for Short Long Cone R2 Custom Default Exposure Values for Short Cone R3 Custom Default Exposure Values for Long Cone R3 Custom 4 7 Exposure Delivery Procedure The moment the keypad console displays the Home screen the unit is ready to deliver an exposure This section de scribes the preparations that can be done before delivering an exposure and what happens during the procedure 29 CHAPTER 4 OPERATING INTRASKAN DC Bring the console back to home screen as shown in figure 19 Here the user can modify the mA and S value The defaults kV Cone and Preset mode can be set during Configuration time See Section 5 3 Figure 19 Home Screen Selecting an Exposure Set proceed as follows An exposure set is a combination of patient type and tooth anatomy which the console uses as an index to retrieve the exposure parameters For each mode there are 8 presets available To select one from these 8 exposure set use the patient type key and the tooth anatomy keys e g to take X Ray image of canine of a child 1 Press the ADULT CHILD key to select child bottom LED 2 Press the CANINE key until the LED is turned on Modifcation of mA amp S values proceed as follows Highlight the parameter By default parameter S is Highlighted S mA ES values of mA is Highlighed and to be altered change the values using Up amp Down kevs If v
30. e image receptor should be placed parallel to the long axis of the teeth as shown by Figure 18 CR Central Ray an imaginary beam of X Rays in the exact center of the position indicating device CR CR perpendicular to long axis of tooth amp film Film parallel to Long axis long axis of tooth of tooth Figure 18 Paralleling Technique ES Refer to Chapter 5 for details on navigating the Kevpad i Console for setup and operation of Intraskan DC 4 4 Power Turn On Procedure Turn on Intraskan by performing the following steps 1 Place the Main Power Switch located on the bottom of the Base Unit to the ON I posi tion See Figure 1 Page 11 ES Do not press keypad keys during self test period Any input will be considered an error at this time 2 On power up observe that the system self check function initiates and the console dis play s Start up Screen as shown by Figure 25 Page 34 3 Immediately following a successful self test the console displays a home screen as shown by Figure 19 page 30 28 CHAPTER 4 OPERATING INTRASKAN DC 4 5 Intraskan DC Operating Procedure Summary Turn on Intraskan DC by performing the Power Turn On Procedure provided in section 4 4 Introduce the receptor into the patient s mouth according to the chosen technique as shown by Figures 17 and 18 bisecting or parallel Page 27 28 Move the tube head beam limiter near the patient and direct it exactly towar
31. ed service support ensure you have entered into an annual maintenance program with your dealer This will ensure that qualified engineers periodically keep a check on the equipment Q Itis advised that the unit be subject to a maintenance schedule once every year after 1st year of usage All servicing should be done by qualified personnel The interior of the Main Assembly is only accessible by removing hardware with tools and should only be opened and serviced by an authorized ImageWorks Dealer Service representative Call your authorized Imageworks dealer for service Since the interior of the unit contains high voltage com ponents failure to heed this warning may result in equipment damage personal injury and or death 6 5 Disposal of the Unit Some parts of the equipment contain material and fluids which must be disposed of at appropriate recycling centers conforming to all local state and federal regulations In particular the equipment contains the following materials and or components Tube head external packages in non biodegradable plastic dielectric oil lead copper brass aluminium tungsten Power supply and remote control external packages in non biodegradable plastic iron populated printed circuit boards copper Tube head extension iron aluminium copper amp silicon rubber Important The Manufacturer and the Distributor do not accept any responsibility for the disposal of equipment or parts discarde
32. effects Warrantv of this equipment will be void in the event of anv modification done to the equipment misuse of the equipment and opening or servicing bv unauthorized personnel 1 1 General Safetv Tips Radiation Safetv This X Rav equipment mav be dangerous to the patient and the operator unless safe exposure parameters and operating instructions are observed Follow proper X Ray radiation safety rules Do not allow exposures The system should be used only by dentists or trained amp qualified dental staff Always point the X Ray tube head at the area to be imaged Patients should be provided with lead apron and thyroid collar while being exposed The operator should wear proper X Ray shielding protection The operator should be at a distance of at least 2 meters away from the tube head while carrying out the procedure The operator should not be standing in the direction of the X Ray The operator should always stand away from the X Ray beam and behind the tube head Electrical Safety Always switch off the main power when cleaning and disinfecting the unit The unit contains lethal high voltages Do not attempt to open covers or repair the unit yourself or with the help of non certified service personnel Contact your authorized dealer This is an ORDINARY MEDICAL EQUIPMENT without protection against ingress of liquids Water or any other liquid should be prevented from leaking into
33. ere a Re Te e ER dA 41 Table A2 X Ray Tube Insert Specifications sse eem nennen nnns 41 Table A3 Mechanical Dimensions and Weight sse enne Re ee ee Re ee ee tnnt 43 Table A4 Mains Power Requirements tette er bti eb Heel Hee bee dass 44 Table A5 Environmental Conditions inem e 44 Table C1 Guidance and Manufacturer s Declaration Electromagnetic Emissions For all EQUIPMENT and SYSTEMS 46 Table C2 Guidance and Manufacturer s Declaration Electromagnetic Immunity For all EQUIPMENT and SYSTEMS 47 Table Guidance Manufacturer s Declaration Electromagnetic Immunity for all EQUIPMENT and SYSTEMS that are not 5 48 This Page is left blank Intentionally GHAPTER 1 SAFETY AND PRECAUTIONS Users must exercise everv precaution to ensure personnel safetv and be familiar with the warnings and cautions presented throughout this manual and summarized below Make sure to read and understand the safetv related instructions Make sure not to modifv anv component of the Intraskan DC svstem Anv modification mav result in violation of compliance to the standards Imageworks shall not be responsible for anv modification causing violation of compliance compromise on safetv performance deterioration or anv other adverse
34. indicating Ensure none of the console keys are active MBOUP pmorende Switch off mains power Wait for 2 minutes Switch on mains power and make sure that none of the console keys are pressed If the problem persists contact authorized service personnel The unit does not power on when Check for loose contact at the wall socket end mains i switched Or the wall outlet is not receiving power Check local electrical circuit for trips Switch off mains power Wait for 2 minutes Switch on mains power If the problem persists contact authorized service personnel No X Ray image even through the Verify film development and storage method The films could be unit indicates normal exposure damaged or the chemicals could be contaminated Contact authorized service personnel to validate exposure quality The mechanical Straight Arm is This can be due to normal wear and tear or using excess force on drifting and does not stay in set the arms position Get the spring tension adjusted by an authorized service engineer Contact authorized service personnel Poor image quality Please make sure that following points are observed Correct exposure values are selected for the anatomy When using film as image receptor its storage and process ing are as recommended by the manufacturer Positioning of tube head and receptor is proper Patient is positioned stably during imaging If the problem persists contact autho
35. ng DSO as shown below Exposure time is measured across test points TP2 and Ground Chassis The exposure time is the time measured between start of kV waveform and start of falling edge from Final Value 42 CHAPTER 8 MEASUREMENT TECHNIQUES Final value of kV kV Exposure time seconds Figure 36 Exposure Time measurement Test procedure 1 Connect the probe of the DSO to TP2 kV feedback with respect to ground mounting screw of control board as shown in the Figure 34 2 Switch ON the AC mains Indication on Control board The fault LED D10 on test control board should not glow red The LED D7 on test control board should glow green colour and the LED D6 green colour on test control board should be blinking every 1 sec approx Indication on Console board Note Do not press any key when console displays the message SELF TEST All LED s should glow during self test amp LCD will display all 3 Red Green amp Blue colours in sequence Console should boot into the home screen without displaying any error message 3 Command exposures through operator console with Kv mA and S settings shown in table below Press amp hold ex posure button till exposure done signal comes in the LCD display Measure and Record the time on Oscilloscope of Error is calculated between set time command and measured time as Error Measured time Set Time Set time x 100 Example Error with 0 045 exposure time
36. nt Closed Loop Tube head current range 4mA 8MA Settable Step size 1mA Accuracy of current lt 5 Maximum Exposure Time 4 seconds Minimum Exposure Time 0 04 s Exposure Timer Accuracy lt 10 Maximum Electrical Input 560W at 70kV 8mA Duty Cycle 1 15 Adaptive amp auto limit based on temperature Additional X Ray filtration Minimum 2 0 mm Al equivalent 70 kV Total X Ray filtration 22 5 mm AL 70 kV Minimum source to skin distance 220 mm x 5mm in built 300 mm x 5mm with optional cone X Ray field at collimator tip Circular daameter s 60 mm SSD of 220 mm and 300 mm Leakage radiation O 1m 0 88 mGy h 100 mR h Leakage radiation technique 70 kV 8 mA 1s Tube head Outer Covers PC ABS Plastic with Glossy Finish PID Cone Material Exten sion Cone Silicone Rubber Aluminium Markrolon 2407 Table A2 X Ray Tube Insert Specifications Parameters Specification Tube Insert Model OX 70 5 Focal Spot IEC60336 0 5 Anode material Tungsten Anode angle 19 Insert Inherent filtration 0 5 mm Al equivalent 70 kV Anode thermal capacity TkJ 44 kJ anode current mA N C fh A Oo N ANNEX A TECHNICAL SPECIFICATIONS exposure time sec Figure A 1 X Ray Tube Insert Rating Chart Figure A 2 X Ray Tube Insert Thermal Data 45 ANNEX A TECHNICAL SPECIFICATIONS 4 HEA
37. nu Increment or decrement parameter value o Toggles between Second mA eed Top LED Second Be d Bottom LED mA Adult Child Toggles between Adult amp Child Preset u i Preset Key Top LED Adult Bottom LED Child Canine Incisor D Canine Incisor preset key LED ON Enable LED OFF Disable Bitewing Bitewing preset key LED ON Enable LED OFF Disable Pre Molar Pre Molar preset key LED ON Enable LED OFF Disable Molar O Molar preset key LED ON Enable LED OFF Disable 25 CHAPTER 4 OPERATING INTRASKAN DC 4 1 Before You Begin Regulator Approvals Film Development Make sure that the operator has read and understood this manual regarding operation of the system Users must exercise every precaution to ensure personal safety and be familiar with the warnings presented throughout this manual and summarized in Chap ter 1 Page 7 Government regulators may require that only a licensed operator may use this equipment Check with your dealer regarding regulations Installation and use of radiation generating equipment is regulated by the government or its authorized agencies in most countries Check with your local dealer regarding site approvals or usage requirements The operator should be well acquainted with the radiation protection methods for both the operator and patient before using this equipment Majorit
38. omatic mode by pressing S mA key In Automatic mode user cannot modify the kV value 34 CHAPTER 5 USING THE KEYPAD CONSOLE To modify kV values in manual mode proceed as follows Manual kV Go to Configuration menu as explained in Section 5 3 Set Select kV option in Configuration menu by using S mA key In Select kV as shown in figure 28 set manual mode by using S mA key Use Up Down key to select the required kV and Figure 29 Manual mode set kV value by pressing S mA key as shown in figure 29 5 3 Configuring Defaults To set the parameters like kV modes and cone as required proceed as follows Press Up and Down key simultaneously to access configuration menu during start up logo The user can set access the following options as shown in the Figure 30 Set exposure mode gt Select kV gt Extension cone gt Receptor 1 gt Save parameters gt Receptor 2 Restore parameters gt Receptor 3 Show feedback gt lt back Service gt continue Automatically Manually gt lt back Short Y Slow Long Fast lt back lt back Always On exposure Never lt back y Always Never lt back Manual kV Firmware version gt Exposure count 00 Exposure history gt Event history gt Event log gt Calib
39. only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions EN 55011 Harmonic emissions EN 61000 3 2 Class A ImageWorks High Frequency Intraoral X Ray is suitable for use in all establishments other than domestic estab lishments and those directly connected to the public low voltage power supply network supplying buildings used for domestic purposes Voltage fluctuations flicker EN 61000 3 3 Complies 49 ANNEX DG GUIDANCE amp MANUFACTURER S DECLARATION Table C2 Guidance and Manufacturer s Declaration Electromagnetic Immunity For all EQUIPMENT and SYSTEMS Immunity Test EN 60601 Test Level Compliance Level Electromagnetic Environment Guidance Floors should be wood concrete or ceramic tile If the floor is covered with synthetic material the relative humidity should be at least 30 Electrostatic dis charge ESD EN E 61000 4 2 ix 2 4 6 kV contact 2 4 6 kV contact 2 4 2 4 6 8 kV air 6 8 kV air 2 Electrical fast tran 2 kV for power sup sient burst EN 61000 ply lines 4 4 1 kV for Signal lines 2 kV for power supply lines 1 kV for Signal lines Mains power quality should be that of a typical commercial or hospital envi ronment 1 kV Differential Surge EN 61000 4 5 mode 2 KV Common 1 kV Differential mode 2 kV Common mode Mains p
40. orange EES If you need to abort while delivering an exposure simply release the Exposure Switch Once the exposure is completed or aborted while delivering the X Ray results screen displays the actual values of kV mA and S sensed The Exposure Switch may be released once the X Ray Results screen displays If the Exposure Switch is continued to be held the next expo sure will not be initiated Results screen would show ABORTED rather than DONE when the exposure procedure was aborted The results screen is shown for 5 seconds if not interrupted by any key press except the Exposure Switch The screen returns to Home screen and is ready for the next exposure ES The tube head needs to cool down before proceeding to the next exposure This waiting period depends on the specific exposure duration selected for the last exposure If an attempt is made to conduct an exposure during this waiting period the console displays a message requesting the operator to wait for the remaining amount of time required by the tube head to cool down 31 GHAPTER 4 OPERATING INTRASKAN DC Table 1 Default Exposure Values for Short Long Cone 1 Film Validated Exposure Values kV mA amp S mentioned below are for minimum patient dose and can be modified as per user requirement Time S Anatomv kV mA plow Fast Cone Short Long Short Long Bitewing 70 8 0 09 0 27 0 07 0 22 Canine 70
41. ower cord Base Unit Internal wiring RJ11 6P4C WITH SINGLE DOORBELL SWITCH Can use Internal Keypad Console with Internal Exposure Switch and single door bell switch 22 CHAPTER 3 KNOW YOUR INTRASKAN DC Configuration 7 Building Power Box Doorbell Doorbell Switch 1 Switch 2 Internal Wiring Mains power cord Base Unit Internal wiring PER 2 Wires 35 MAX RJ11 6P4C WITH DOUBLE DOORBELL SWITCH Can use Internal Keypad Console with Internal Exposure Switch and double door bell switch SETA Intraskan DC Floor Mount unit is powered directly through a Hospital grade Plug For Intraskan DC Floor Mount unit exposure is given using Internal Exposure Switch as in Wall Mount Configuration 1 Intraskan DC Wall mounting Configurations 2 Stud Mounting Single Stud Mounting 23 CHAPTER 3 KNOW YOUR INTRASKAN DC 3 5 Keypad Console All functional operating control of Intraskan DC is provided by the keypad Console located on the base unit consist ing of a LCD display and keypad Apart from this Remote Keypad Console External Console with Doorbell Switch and Doorbell Switch also is available as an optional accessorv This additional console will be used for different configurations of console as illustrated in Section 3 4 It allows both automatic and manual selections of exposure parameters The location of the panel controls and indicators are shown by Figure 14 while the function of ea
42. ower quality should be that of a typical commercial or hospital envi ronment mode lt 5 UT gt 95 dip in UT for 0 5 cycle lt 5 UT gt 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 40 UT 60 dip in UT for 5 cycles Mains power quality should be that of a typical commercial or hospi tal environment If the user of the Imageworks High Frequency In traoral X Ray requires continued operation during power mains inter ruptions it is recommended that this High Frequency Intraoral X Ray be powered from an uninterruptible power supply or a battery Voltage dips short interruptions amp volt age variations on power supply input lines EN 61000 4 11 70 UT 30 dip in UT for 25 cycles 70 UT 30 dip in UT for 25 cycles lt 5 UT gt 95 dip in UT for 5 sec lt 5 UT gt 95 dip in UT for 5 sec Power frequency magnetic fields should be at levels characteristic of a typical location in a typical com mercial or hospital environment Power frequency 50 60 Hz magnetic field EN 61000 4 8 50 ANNEX C GUIDANCE amp MANUFACTURER S DECLARATION Table C3 Guidance and Manufacturer s Declaration Electromagnetic Immunity for all EQUIPMENT and SYSTEMS that are not LIFE SUPPORTING Immunity Test EN Nd Compliance Level Electromagnetic Environment Guidance Conducted RF 3 Vrms 3 Vrms Portable mobile RF communications equipment should EN
43. p tor The keypad Console of Intraskan DC provides a total of three user modes of operation which include One factory programmed default modes R1 Film L Two custom modes R2 amp R3 Each mode provides 8 sets of exposure parameters based on the patient type and tooth anatomy The factory programmed modes varies the exposure duration to suite the accessories cone type and film speed se lected Change the Preset Mode by performing the procedure provided below SET EXPOSURE MODE Receptor 1 gt Receptor 2 Receptor 3 lt Back Figure 27 Mode Selection Screen 5 2 Selecting kV Mode Selection Screen Go to Configuration menu as explained in Section 5 3 Use the UP DOWN keys to navigate within the list Press these buttons until the desired mode is highlighted Select Set Exposure Mode by pressing S mA key Ascreen similar to the one shown on the left side appears on the display User can select one mode among these by pressing S mA key By pressing Adult Child key to returns home screen with the newly se lected mode abbreviated on the top right side of the display kV can be modified only in Manual mode To set Automatic mode proceed as follows Select kV Automatically Manually gt lt Back Figure 28 Automatic mode Go to Configuration menu as explained in Section 5 3 Set Select kV option in Configuration menu by using S mA key In Select kV as shown in figure 28 set Aut
44. raskan DC Reach Dimensions and Movements Figures 3 through 12 show minimum and maximum clearances dimensions and sweep angles for both the wall mount ed and Floor Mount units 15 Straight Arm 380mm 15 1300mm 51 1465mm 58 to 310 1549mm 61 La 165mm 6 520 to 540 155 to 165 200 to 210 Figure 3 Wall Mounted Intraskan DC 15 Support Tube Fully Extended Right Side and Top Views 14 CHAPTER 3 KNOW YOUR INTRASKAN DC 24 Straight Arm 610mm 24 1300mm 51 300 to 310 1695mm 67 1803mm 71 520 to 540 155 to 165 200 to 210 Figure 4 Wall Mounted Intraskan DC 24 Support Tube Fully Extended Right Side and Top Views 33 Straight Arm 830mm 33 1300mm 51 58mm 2 1915mm 75 165mm 6 2032mm 80 155 to 165 520 to 540 200 to 210 Figure 5 Wall Mounted Intraskan DC 33 Support Tube Fully Extended Right Side and Top Views 15 CHAPTER 3 KNOW YOUR INTRASKAN DC a rare 356mm ay Pf ICT g 1393mm 55 576 23 205 8 Y Floor Level Figure 6 Wall Mounted Intraskan DC Ground Clearance amp Horizontally Extended i LT EE EN oi ae Ad Ra AE EER T gt qal ep EED aU 762mm 30 itt E 1244mm 49 576mm 23 356mm 14
45. rate gt lt back Figure 30 Configuration Screen L Use Up Down key to navigate within Configuration menu L Press S mA key to accept currently highlighted item L Press Adult Child key to return previous menu 35 GHAPTER 5 USING THE KEVPAD CONSOLE 5 4 Console Events This section describes the special events displayed in the Keypad console For Attention Warning mes sages refer Table 5 and for error codes refer Table 7 Inactive Absence of any activity for 10 minutes continuously on the console causes the system to go to a state of inactivity This is marked by ImageWorks the screen indicating a message as shown on the left side along with the display backlight driven into a breathing state Press Press any key to bring the console back to the Home screen Figure 31 Stand by Screen Error Any error occurring in the system is reported by the console as System error follows Code CNOO9 e Displays an error message with an error code and additional please restart messages example code shown is CNOO9 Display backlight turns RED Anexposure can not be delivered until the issue is resolved Figure 32 Error Display Table 5 Attention Warning Messages Tube cooling Home EXPOSURE key pressed after an exposure Please wait and before the cooling period expires n seconds System Home After fixing an internal error while exposing lt error Please
46. rce Assembly Tube head capable of generating X Rays This X Ray unit may be dangerous to patient amp operators unless safe exposure factors and operating instructions are observed WEEE Symbol of only at the appropriate facilities for recovery and recycling X Ray Emission Status Indicates that the unit conforms with WEEE Directive 2002 96 EC and must be disposed X Ray Emission ON Focal Spot Mains Neutral Connection Mains Line Connection gt gt gt oP Follow Instructions for use CHAPTER 2 INTRODUCTION 2 1 Intraskan DC X Ray Equipment The Intraskan DC High Frequency Intraoral X Ray has been engineered and manufactured to provide many years of reliable service The system houses two microprocessors one for control supervisory functions and another to provide the user machine interface The technology incorporates feedback circuits to ensure accuracy and reproducibility of X Ray output for dental diagnostic radiography Intraskan DC will create radiographs of excellent quality performing equally well using any image receptor The High Frequency Intraoral X Ray is hereafter referred to as Intraskan DC in this manual Review and follow the guidelines included in this User s Manual to thoroughly become familiar with the operating and safety procedures This will ensure that your Intraskan DC gives you the highest level of service 2 2 Indication for Use The Imageworks High
47. red field strength in the location in which Intraskan DC is used exceeds the applicable RF compliance level above the Imageworks High Frequency Intraoral X Ray should be Observed to verify normal operation If abnormal performance is observed additional measures may be neces sary such as reorienting or relocating the Imageworks High Frequency Intraoral X Ray Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 51 ANNEX D CONTACT DETAILS Corporate Head Quarters Factory ImageWorks and Technical Support 250 Clearbrook Road Suite 240 Elmsford NY 10523 USA 1 914 592 6100 Voice 1 800 592 6666 Toll Free 1 914 592 6148 Fax Web www imageworkscorporation com 52 Title ImageWorks Customer Feedback Form Page 1 of2 Notes 1 Details are essential 2 Attach additional sheet if required 3 Read all instructions before filling up 4 Completed format can be sent to address as given below or in website www imageworkscorporation com 5 for any more clarification please contact ImageWorks A Feedback by Customer Customer Address Street City State Pin Zip Code Country Customer Phone Number Senders Full name Senders Cell Phone amp Senders e mail ID B Product details Product Full System Type Model Product Application Installed Site Address C Feedback
48. rized service personnel 40 CHAPTER 8 MEASUREMENT TECHNIQUES 8 1 Direct measurement method Instruments used in kV mA and timer accuracies measurement Make 01 DSO 200Mhz YOKOGAWA DLM2024 Any Equivalent equipment can be used with valid calibration Abbreviations used kV Tube potential mA Tube Current S Exposure time DSO Digital storage oscilloscope Tube Potential testing method Tube potential measurement is direct method by using potential divider and DSO as shown below Potential divider is inbuilt into the INTRASKAN DC and measurement point TP2 on the control board refer figure 34 provided for hooking measuring probe 35kV NA T 600Meg amp Resistor inside Tank gt gt kV_Anode N amp 15K G RO U ND E 27n Mounting Screw B z TP2 Averaging Circuit gt gt TO DSO 1V 13 333kV L 5 25V 70kV 0 2 5 2 7n G 2 5 9 gt gt kV Cathode a 600Meg gt HV Resistor inside Tank x N 35kV Figure 33 kV Feed back circuit Figure 34 Test Points Test procedure Production test will be performed with nominal input voltage 110Vac 60Hz 1 Connect the probe of the DSO to TP2 kV feedback with respect to ground mounting screw of control board as shown in the Figure 34 2 Switch ON the AC mains Indication on Control board The fault LED D10 on test control board should not glow red The LED D7 on test control board should glow green
49. s engineered to provide the best platform for dental radiographic imaging However the best results are obtained when the equipment is used properly per the manufacturer s specifications Practicing the following positioning tech niques will help the user make the best out of the equipment s output Patient s Head Position L Patients head should be as straight as possible Q The patient should not move during the exposure Cone Position Q Cone should be positioned in such a way that the central axis of the cone is perpendicular to the teeth and should be as close to the area being imaged as possible Q In general the vertical angulation of the cone should be at 45 for maxilla teeth and 10 for Mandible teeth L The horizontal angulation of the cone should also be maintained to achieve perpendicularity with respect to the teeth as shown by Figure 17 below Re The angle of the cone is indicated on the scale located on the vertical joint of the tube head M Molar Pre Molar C Canine Maxilla Mandible ML Sagittal Plane Sagittal Plane Figure 17 Horizontal Angulation 27 CHAPTER 4 OPERATING INTRASKAN DC Ex The Image Receptor and holder are not part of supplied accessories Image Receptor Holder Using an image receptor holder and head positioning device is recommended since it gives precise control over the area to be imaged Placement of Image Receptor Inside the Patient s Mouth Th
50. sposable towel moistened with water 6 2 Caring For Your Equipment Do not allow the unit to impact with any hard surfaces Switch off the unit when leaving for the day or when not used for a long time Ensure that the unit is not subject to direct sunlight Do not force the arm mechanisms or tube head into a position it is not designed for There are move ment stoppers provided Avoid swinging the arms or rotating the tube head in a sudden jerky manner Avoid free swinging of the arms or tube head Always guide the movements with your hand Do not hang external loads or weights on the tube head or Straight Arm The arm and base units are designed for its own weight and may not hold an additional weight L LLL Peo Schedule and carry out periodic maintenance checks 37 GHAPTER MAINTENANCE 6 3 Shipping Long Term Storage and Tube seasoning Q Use the original packing box for shipping transporting the unit LJ When not using for a long time cover the unit with dust proof covers and ensure the unit is not exposed to harsh environments In case of non usage for long period 26 months X Ray Tube Seasoning is recommended Cover the X Rav port with Lead Using the Kevpad Console set the parameters per Table below Give Exposure and repeat exposure 5 times for each combination of kV mA and S After all the exposures are completed the Unit is readv for use Table 6 6 4 Preventive Maintenance For continu
51. template Optional 9992720001 10 3 1 CHAPTER 3 KNOW YOUR INTRASKAN DC Key Component Identification As shown in Figure 1 Intraskan DC is comprised of the following components 1 Base Unit Both Wall mount and Floor Mount Units The Base Unit provides mounting support for the straight arm and scissor arm with attached tube head It provides system power connection and application via the Mains Power Line Cord and the Mains Power ON OFF Switch Overall operational control for Intraskan DC is also provided via the Keypad Console Keypad Console Both Wall mount and Floor Mount Units The Keypad Console is the user machine interface providing all functional operating controls of the Intraskan DC system Consisting of a LCD display and keypad the console keypad allows both automatic and manual selections of exposure parameters while the resultant operation status is shown via the LCD display Straight Arm Wall mount Units The Straight Arm provides the horizontal space away from the wall mounted Base Unit Available in 15 24 and 33 inch lengths to meet the reach requirements of the installation site Scissor Arm Both Wall mount and Floor Mount Units The Scissor Arm consists of a vertical and horizontal arm joined via a double joint This design enables smooth linear and upward motion transitions while allowing the attached tube head to remain balanced in all positions Mobile Support Platform Floor Mount Units The
52. uration Screen ta tea ee e e ite ede le de Figure 31 stand by Screen od e Eee re de MO e e e ed ba Figure 32 Error Display EE Figure 33 kV Feed back circuit ee GEE RS estan ede de eni de ea e de has Figure 34 TEST PONS a AE ER EA EE a Figure 35 mA Feed back circuit 3 tei ee es see niet i ER Ek ee Figure 36 Exposure time measurements rrenan Figure 37 kV measurement using KVP sensor renan Figure A 1 X Ray Tube Insert Rating Chart sr ee Ge RR nn ee meer nennen Figure A 2 X Ray Tube Insert Thermal Data sssri ee se nn ee ee ke ee ee ee Figure Heating and Cooling CUNE iis ese sees ee se Ge Ge Re ede GR Re be Ge Ge bee Ge Ee Re ee Gee eke LIST OF TABLES Table A Key Description x ie EE E eR E E edet 25 Table 1 Default Exposure Values for Short Long Cone R1 Film 32 Table 2 Default Exposure Values for Short Long Cone R2 eene 32 Table 3 Default Exposure Values for Short Cone R3 nn 33 Table 4 Default Exposure Values for Long Cone sse eene 33 Table 5 Attention Warning Messages eene eese Ge EA GR GE an Ge AR Gee se EA bee ee 36 Table 6 Tube seaSONning e A i Eg 38 Table 7 Error Codes ii die nmn daos 39 Table 8 Troubleshooting Tips aceite iot edite cae e estet Ee pedi de We Ge Ee v eee 40 Table A1 T be Head Specifications sissien an mera tene re er tere
53. user requirement Time S Anatomy kV mA Cone Long Bitewing 70 6 0 33 Canine 70 8 0 25 Adult Molar 70 8 0 25 Pre Molar 70 8 0 25 Bitewing 70 8 0 18 Canine 70 8 0 18 Child Molar 70 8 0 18 Pre Molar 70 8 0 18 33 GHAPTER 5 USING THE KEVPAD CONSOLE The keypad Console is the user interface allowing the operator to control the X Ray system and get feedback from it This section describes how to use the console to complete specific tasks As a preface the stages through which the console passes before it becomes operable are described first ImageWorks Figure 25 Start up Screen Figure 26 Home Screen 5 1 Selecting a Preset Mode Power up Indication On power up the console displays the Start up Screen as shown on the left Following this the console performs self test The keypad beeper and LCD backlight are checked Do not press any keys including exposure switch during self test period Home Screen Immediately following a successful self test the console displays a screen similar to the one shown on the left This screen displays current selection of exposure parameters exposure mode details and accessories selected cone type and film speed A READY icon at the top right corner of the display indicates that the sys tem is ready to deliver an exposure A Preset Mode is a collection of exposure parameters kV mA and S suitable for a particular type of image rece
54. xposure Switch Configuration 2 Building Power Box Remote Internal Wiring Es Keypad console Mains power cord Base Unit RJ45 8P8C with single door bell switch Can use both Keypad Consoles internal and remote with Internal Exposure Switch and single door bell switch 20 CHAPTER 3 KNOW YOUR INTRASKAN DC Configuration 3 Building Power Box Remote t Keypad Doorbell Internal Wiring console Switch 2 Mains power cord Base Unit RJ45 8P8C i 36 2 Wires MAX Internal wiring RJ45 8P8C with DOUBLE DOORBELL SWITCH Can use both Kevpad Consoles internal and remote with Internal Exposure Switch and double door bell switch Configuration 4 Building Power Box es Doorbell Switch 2 Internal Wiring Mains power cord Base Unit Internal wiring Bones 35 MAX 3 WIRE WITH SINGLE DOORBELL SWITCH Can use Internal Keypad Console with Internal Exposure Switch and single door bell switch 21 CHAPTER 3 KNOW YOUR INTRASKAN DC Configuration 5 Building Power Box Doorbell Doorbell Switch 1 Switch 2 Internal Wiring Mains power cord Base Unit Internal wiring 2 Wires 35 3 WIRE WITH DOUBLE DOORBELL SWITCH Can use Internal Keypad Console with Internal Exposure Switch and double door bell switch Configuration 6 Building Power Box Doorbell Internal Wiring Switch 2 Mains p
55. y of repeat exposures and inferior X Ray images are attributed to the storage handling use and developing of X Ray films rather than the equipment itself Make sure that the image capture films are stored and used per instructions Let the patient know that he she is going to be exposed to X Ray Avoid X Rays or take necessary precautions when X Raying pregnant patients 4 2 Positioning the Patient Adults T Children T Position Indicating Device The patient shall be seated and made comfortable so that he she does not move during the exposure Make sure to place protective aprons and shields over the patient where necessary For young patients it may be required that a guardian be available near the patient In such cases instruct the guardian to be on the same side of the X Ray port away from the X Ray beam and behind the tube head The guardian shall wear radiation protective clothing The Position Indicating Device PID also referred to as the Cone should be used to approximate the area of X Ray exposure DES The tube head has an builtin focus to skin distance of 220mm 4 5mm This is also referred as short cone distance which is the safe distance at which the skin can be positioned Optionally the operator can use long cone Long cone will increase the focus to skin position distance from 220mm 5mm to 300mm 5mm 26 CHAPTER 4 OPERATING INTRASKAN DC 4 3 Achieving the Best Image Quality Intraskan DC i
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