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HATCH X-RAY Operating Manual

ANNEX

DECLARATION OF CONFORMITY

B1: Name and description of product

Medical Device Name

: High Frequency Dental X-Ray System

Medical Device Model

: Hatch X-Ray

Device variants:

303-00238X-0 - Hatch X-Ray X-ray with focal spot size 0.4 in wall mount

configuration with Extension arm, where X= 1,2,3

B2: Following standards under which conformity is declared

ANSI/AAMI ES 60601-1: A1:2012 C1: 2009/(R) 2012 and A2:2010/(R) 2012
IEC 60601 - 1: ED 3.1 (2012)
CAN/CSA-C22 .2 No. 60601-1:14
IEC60601-1-2:2014
IEC 60601-1-3: 2008 + A1:2013
EN/IEC 60601-2-65 2012
IEC60601-2-28: 2010
CMDR SOR/98-282

B3: Marking

The products described herein are conform to the following regulatory markings

a. UL safety marking.

Summary of Contents for X-RAY

Page 1: ...OPERATING MANUAL ...

Page 2: ...HATCH X RAY Operating Manual 1 Document Number UMN 004627 0 20 Document Revision Rev 01 Publication Language English Part Number 515 004627 0 ...

Page 3: ...THIS PAGE IS LEFT BLANK INTENTIONALLY HATCH X RAY Operating Manual ...

Page 4: ... 16 3 5 Keypad Console 20 4 OPERATING THE UNIT 23 4 1 Before You Begin 23 4 2 Positioning the Patient 23 4 3 Achieving the Best Image Quality 24 4 4 Power Turn On Procedure 26 4 5 Hatch X Ray Operating Procedure Summary 26 4 6 Exposure Settings and Tables 27 4 7 Exposure Delivery Procedure 28 5 USING THE CONTROL CONSOLE 37 5 1 Selecting a Pre set Mode 37 5 2 Selecting a Pre set 38 5 3 Modifying Ex...

Page 5: ...ipment 45 6 3 Shipping and Long Term Storage 46 6 4 Preventive Maintenance 47 6 5 Disposal of the Unit 47 6 6 Optional Accessories 48 7 TROUBLESHOOTING 49 Annex A TECHNICAL SPECIFICATIONS 51 Annex B DECLARATION OF CONFORMITY 57 Annex C GUIDANCE AND MANUFACTURER S DECLARATION 59 Annex D CONTACT DETAILS 65 ...

Page 6: ...ady 28 Figure 11 X Ray Exposing 28 Figure 12 X Ray results 29 Figure 13 Start up screen 37 Figure 14 Home screen 37 Figure 15 Mode selection screen 38 Figure 16 Home screen with mS highlighted 39 Figure 17 mS parameter being modified blinking 39 Figure 18 mS parameter modified and accepted kV highlighted 39 Figure 19 Setting a Start up Mode 40 Figure 20 History screen 40 Figure 21 Configuration Sc...

Page 7: ...ning Messages 43 Table 9 Tube seasoning 46 Table 10 Hatch X Ray Optional Accessories 48 Table 11 Error codes 49 Table 12 Troubleshooting tips 50 Table A1 Tube Head specifications 52 Table A2 X Ray tube insert specifications 52 Table A3 Mechanical dimensions and weight 54 Table A4 Mains power requirements 55 Table A5 Environmental conditions 55 Table C1 Guidance and Manufacturer s Declaration Elect...

Page 8: ...ce 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 The expected service life of the product is determined based on design considerations and field performance of similar devices The expected se...

Page 9: ... is missing or damaged notify your authorized dealer Table 1 Hatch X Ray System Components Wall Mounted Description Part No Hatch X Ray X RAY FS04 Wall Mount 15 Extension arm F303 002381 0 Hatch X Ray X RAY FS04 Wall Mount 24 Extension arm F303 002382 0 Hatch X Ray X RAY FS04 Wall Mount 33 Extension arm F303 002383 0 Extension arm Assembly one only Used with Wall Mount Units Only 15 Inches Long us...

Page 10: ...pment will be void in the event of any modification done to the equipment misuse of the equipment and opening or servicing by unauthorized personnel 2 1 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 Type of Insulation Class 1 Type B Insulation P...

Page 11: ... Connection N Mains Neutral Connection X Ray Emission ON Protective earth Mains Earth is required for continued protection against shock hazards WEEE Symbol Follow proper procedures for disposing this equipment Cannot be disposed as general waste ...

Page 12: ...3 Extension arm The Extension 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 4 Scissor Arm 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 r...

Page 13: ...Labels This section lists the labels that are affixed on the unit Please refer to Figure 2 for the location where they are affixed The mark number is given against each label below Label 1 Base Unit Label Label 2 Tube Housing Label for focal spot 0 4 Label 3 Tube Housing Sl No Label ...

Page 14: ...Label 5 Hatch X Ray Logo Label 6 Angular Tape Label 7 Extension Cone Label Label 8 Scissor Arm Label Label 9 Manufacturer Label Label 10 Extension Arm Label Label 11 Base Unit Sl No Label Label 12 Console Label Label 13 Danger Label Label 14 Warning Label ...

Page 15: ...HATCH X RAY Operating Manual 14 Label 15 Radiation Caution Label Label 16 UDI Label Label 17 UL Mark Label Label 18 Input Configuration Label Figure 2 Label Location ...

Page 16: ...re 5 show minimum and maximum clearances and dimensions for wall mounted Figure 3 Wall Mounted Hatch X Ray Fully Extended Right Side and Top Views Extension Arm Lenght A Max Reach to Wall B 15 381mm 62 1575mm 24 610mm 71 1803mm 33 838mm 80 2032mm Figure 4 Wall Mounted Hatch X Ray Ground Clearance ...

Page 17: ...Hatch X Ray Wall mount Configurations Can use Internal Keypad Console and Internal Exposure Switch Optional NOTE For Configurations 2 7 RJ45 8P8C 35 Cable CAT 5 24AWG 4 Twisted Pair 1 1 Connection RJ11 6P4C 35 Cable Center 4 Positions Populated 1 1 Connection 3Wire 35 Cable Shielded or Un shielded Cable AWG 20 28 ...

Page 18: ...h optional Can use both Keypad Consoles internal and remote with Internal Exposure Switch and single door bell switch RJ45 8P8C with DOUBLE DOORBELL SWITCH optional Can use both Keypad Consoles internal and remote with Internal Exposure Switch and double door bell switch ...

Page 19: ...SINGLE DOORBELL SWITCH Can use Internal Keypad Console with Internal Exposure Switch and single door bell switch 3 WIRE WITH DOUBLE DOORBELL SWITCH optional Can use Internal Keypad Console with Internal Exposure Switch and double door bell switch ...

Page 20: ...SINGLE DOORBELL SWITCH Can use Internal Keypad Console with Internal Exposure Switch and single door bell switch RJ11 6P4C WITH DOUBLE DOORBELL SWITCH optional Can use Internal Keypad Console with Internal Exposure Switch and double door bell switch ...

Page 21: ... selected exposure parameters along with many other user friendly features The screen components of the home screen are shown by Figure 6 and the associated Detail A 3 5 2 Keypad In addition to the LCD display the keypad Console contains 11 keys and exposure LED indicator These keys are used to select the exposure parameters Hatch X Ray simplifies the process of selecting exposure parameters using...

Page 22: ... exposure as set by desired procedure mode Figure 6 Hatch X Ray Keypad Console with LCD Display Exposure Status LED Indicator Extinguished Idle Standby Green Ready to Deliver X Ray Orange Exposure in Progress Red Operation Fault UP DOWN Keys Navigate up or down a list menu Increment or decrement parameter value ...

Page 23: ...Selects among Bitewing Endodontic Normal Exposure Preset Top LED Bitewing Bottom LED Endodontic Both LEDs off Normal Exposure Occlusal Preset Key Toggles between Maxillary Mandibular Occlusal Preset Top LED Maxillary Bottom LED Mandibular Molar Preset Key Toggles between Maxillary Mandibular Molar Preset Top LED Maxillary Bottom LED Mandibular Premolar Canine Preset Key Toggles between Maxillary M...

Page 24: ...jority 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 Ensure that the image capture films are stored and used as per instructions Let the patient know that she is going to be X Rayed Avoid X Rays or take necessary precautions when X Raying pregnant patients 4 2 Positioning the Patient Adults Th...

Page 25: ...ing However the best results are obtained when the equipment is used the right way Practicing the following points will help the user make the best out of the equipment s output Patient s Head Position Patient s head should be as straight as possible The patient should not move during the exposure Cone Position Cone should be positioned in such a way that the central axis of the cone is perpendicu...

Page 26: ...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 Image receptor should be placed parallel to the long axis of the teeth Figure 8 Paralleling Technique CR Central Ray is an imaginary beam of X Rays in the exact centre of the position indicating device ...

Page 27: ...ing the Power Turn On Procedure provided in section 4 4 2 Introduce the film plate or sensor into the patient s mouth according to the chosen technique as shown by Figure 7 and Figure 8 bisecting or parallel 3 Move the tube head beam limiter near the patient and direct it exactly towards the tooth to be examined 4 Arrange the tube head with an angle suitable for the required exposure and positioni...

Page 28: ... 2 Default Exposure Values for Short Long Cone Slow Film Mode 1 Table 3 Default Exposure Values for Short Long Cone Fast Film Mode 1 Table 4 Default Exposure Values for Short Long Cone Mode 2 Table 5 Default Exposure Values for Short cone PSP Table 6 Default Exposure Values for Long cone PSP Table 7 Default Exposure Values Custom Modes All In order to avoid accidental exposure the user is advised ...

Page 29: ... the procedure in section 5 3 Modifying Exposure Parameters Figure 10 X Ray Ready 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 pre...

Page 30: ... 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 Dose is directly proportional to mA and mS for a given kV Estimated Exposure Values kV mA ms mentioned below are for minimum patient dose and can be modified as per user requirement The inverse s...

Page 31: ... 140 400 11 93 33 7 Molar Maxilla 70 6 220 710 18 76 60 25 Mandible 70 6 160 450 13 65 38 1 Occlusal Maxilla 70 6 250 710 21 15 60 25 Mandible 70 6 250 710 21 15 60 25 Child Bitewing 70 8 71 200 5 99 16 9 Endodontic Incisors Maxilla 70 6 110 320 9 35 27 34 Mandible 70 8 71 200 5 99 16 9 Canine Maxilla 70 6 140 450 11 93 38 1 Mandible 70 6 100 280 8 49 23 88 Molar Maxilla 70 6 160 500 13 65 42 41 M...

Page 32: ...e 70 6 110 320 9 35 27 34 Molar Maxilla 70 6 180 560 15 32 47 4 Mandible 70 6 125 360 10 56 30 3 Occlusal Maxilla 70 6 200 630 17 05 53 37 Mandible 70 6 200 630 17 05 53 37 Child Bitewing 70 8 50 140 4 25 11 9 Endodontic Incisors Maxilla 70 6 80 220 6 8 18 76 Mandible 70 8 50 140 4 25 11 9 Canine Maxilla 70 6 110 320 9 35 27 34 Mandible 70 6 71 200 6 17 05 Molar Maxilla 70 6 125 320 10 56 27 34 Ma...

Page 33: ...70 6 140 160 11 9 3 13 65 Molar Maxilla 70 6 140 140 11 93 11 93 Mandible 70 6 140 140 11 93 11 93 Occlusal Maxilla 70 6 140 140 11 93 11 93 Mandible 70 6 140 140 11 93 11 93 Child Bitewing 70 8 90 90 7 65 7 65 Endodontic Incisors Maxilla 70 6 110 110 9 35 9 35 Mandible 70 8 80 80 6 80 6 80 Canine Maxilla 70 6 125 125 10 56 10 56 Mandible 70 6 125 125 10 56 10 56 Molar Maxilla 70 6 125 125 10 56 1...

Page 34: ... 8 140 Mandible 70 8 140 Molar Maxilla 70 8 160 Mandible 70 8 160 Occlusal Maxilla 70 6 360 Mandible 70 6 360 Child Bitewing 70 8 110 Endodontic Incisors Maxilla 70 8 100 Mandible 70 8 100 Canine Maxilla 70 8 110 Mandible 70 8 110 Molar Maxilla 70 8 125 Mandible 70 8 125 Normal Exposure Incisors Maxilla 70 8 110 Mandible 70 8 110 Canine Maxilla 70 8 110 Mandible 70 8 110 Molar Maxilla 70 8 125 Man...

Page 35: ... 6 360 Mandible 70 6 320 Molar Maxilla 70 6 360 Mandible 70 6 360 Occlusal Maxilla 70 6 450 Mandible 70 6 450 Child Bitewing 70 8 180 Endodontic Incisors Maxilla 70 8 180 Mandible 70 8 180 Canine Maxilla 70 8 180 Mandible 70 8 180 Molar Maxilla 70 8 180 Mandible 70 8 180 Normal Exposure Incisors Maxilla 70 8 180 Mandible 70 8 180 Canine Maxilla 70 8 180 Mandible 70 8 180 Molar Maxilla 70 8 180 Man...

Page 36: ...5 8 200 19 3 Mandible 65 8 160 15 42 Molar Maxilla 65 6 360 33 93 Mandible 65 8 200 19 3 Occlusal Maxilla 70 8 200 22 78 Mandible 70 8 200 22 78 Child Bitewing 60 8 160 12 77 Endodontic Incisors Maxilla 60 8 140 11 21 Mandible 60 8 100 7 98 Canine Maxilla 60 8 140 11 21 Mandible 60 8 125 9 84 Molar Maxilla 60 8 200 15 97 Mandible 60 8 160 12 77 Normal Exposure Incisors Maxilla 60 8 140 11 21 Mandi...

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Page 38: ...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 bottom right corner of the display indicates that the system is ready to deliver an exposure The icon when present indicates that current combination of Preset Mode and Anatomy are different from the default startup comb...

Page 39: ...for current session Hence the option will not be available before the first exposure On choosing this option a list containing previous 40 exposures are displayed Scroll through the list using the arrow keys and press SET key to use the highlighted item 5 2 Selecting a Pre set A pre set is a combination of patient type and tooth anatomy which the console uses as an index to retrieve a pre programm...

Page 40: ...dified blinking Modify the parameter Press UP DOWN keys the required number of times to change the highlighted parameter The parameter being changed blinks to indicate the operation NOTE The READY icon disappears to indicate that an exposure is not possible until the change is accepted rejected Figure 18 mS parameter modified and accepted kV highlighted Accept Reject the change Press SET key to ac...

Page 41: ... up mode At this point the icon disappears to indicate that current combination is saved as the default start up mode 5 5 Using Previously Used Exposure Parameters The console stores the last 30 exposures in its internal memory and is not erased by a power down You may use one of these exposure details to deliver a new exposure Figure 20 History screen Return to Home Screen Press MODE key to enter...

Page 42: ...hanges are made scroll down to Save and Return and press SET key Triggering Cancel returns to Mode Selection Screen without accepting the changes made 5 7 Console Events This section describes the special events displayed in the Keypad console For Attention Warning messages refer Table 8 and for error codes refer Table 11 Figure 22 Stand by screen Inactive Absence of any activity for 5 minutes con...

Page 43: ...tomy is the default start up combination ATTENTION Not available in History mode Home Exposure Access keys pressed when History preset mode is selected ATTENTION Press UP DOWN to scroll SET to accept or MODE to cancel History Mode Selection Any one of the following keys pressed 1 SEL 2 EXPOSURE or 3 Exposure Access ATTENTION Press SET to accept change or SEL to discard Parameter Modification Any o...

Page 44: ... mA is more than 6mA Tube cooling Please wait n seconds Home EXPOSURE key pressed after an exposure and before the cooling period expires System ready Recovered from error code Please retry Home After fixing an internal error while NOT exposing System error error code Please retry Home After fixing an internal error while exposing ERROR error code Please restart Home After an internal error that r...

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Page 46: ...ng procedures NOTE Make sure that the unit is completely dry before plugging in or turning 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 Disinfectan...

Page 47: ...e unit 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 6 months X Ray tube seasoning is recommended Cover the cone with lead Using the control console set the parameters as per table below Give exposure and repeat exposure 5 times for each combination of kV mA and ms After all the exp...

Page 48: ...e representative Call your authorized Hatch X Ray dealer for service Since the interior of the unit contains high voltage components 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 fede...

Page 49: ...t your Hatch X Ray Dealer for additional information Description Part No Hatch X Ray Extension Cone Hatch X Ray 15 inch Extension arm Hatch X Ray 24 inch Extension arm Hatch X Ray 33 inch Extension arm Hatch X Ray Aesthetic Kit includes rubber caps plugs Hatch X Ray Keypad Console Hatch X Ray Remote Keypad console Hatch X Ray Doorbell switch Hatch X Ray Aesthetic Wall plate Table 10 Hatch X Ray Op...

Page 50: ...1 below The table lists the code and identifies the corresponding equipment operational fault The corrective action for the error code is provided by Table 12 which also lists observed problems and their potential source Error Code Error CN001 Communication error CN002 Console and tube head are incompatible CN003 X Ray preparation time out CN004 Anode arc fault CN005 Cathode arc fault CN006 Over K...

Page 51: ...f neon lamp is on then check the following Ensure that the spiral cable connection to the base is proper Switch off mains power Wait for 2 minutes Switch on mains power If the problem persists request service call 4 No X Ray image even through the unit indicates normal exposure Verify film development and storage method The films could be damaged or the chemicals could be contaminated Log a servic...

Page 52: ... High Voltage Rise Time 3ms Control of Tube Current Closed Loop Tube head current range 4mA 8mA Settable Step size 1mA 7 8mA time 200ms Accuracy of current 5 10 for time 40ms Maximum Exposure Time 3 5s upto 6mA 7 8 mA 200ms Max Minimum Exposure Time 10 ms Exposure Timer Accuracy 10 Maximum Electrical Input 560W at 70kV 8mA Duty Cycle 1 15 Adaptive auto limit based on temperature Additional X Ray f...

Page 53: ...ubber Aluminium Makrolon 2407 Table A1 Tube Head specifications X Ray Tube Insert Specifications Parameters Specification Tube Insert Model OX 70 4 Focal Spot IEC336 0 4 Anode angle 16 Anode material Tungsten Insert Inherent filtration 0 5 mm Al equivalent 70 kV Anode thermal capacity 7 kJ Table A2 X Ray tube insert specifications Figure A 1 X Ray Tube Insert Rating Chart OX 70 4 ...

Page 54: ...HATCH X RAY Operating Manual 53 Figure A 2 X Ray Tube Insert Thermal data OX 70 4 Figure A 3 Heating and cooling curve Product s tube inserts OX 70 4 ...

Page 55: ...sion arm 71 33 Extension arm 80 Height of unit with Arms folded 51 0 5 Support Tube Rotation about Base 180 10 Scissor Arm Swing Wall Mount 220 10 Tube Head swivel on horizontal plane 530 10 Tube Head rotation about Vertical Plane 305 5 Table A3 Mechanical dimensions and weight Mains Power Requirements Line voltage range 100 110V 230 240V AC 10 Range of line voltage regulation for operation at max...

Page 56: ... I Type B Electrical Connection Line Neutral and Earth Earth is mandatory 1 Phase Table A4 Mains power requirements Environmental Conditions Operating conditions Temperature 10 C to 40 C Humidity 25 to 75 Altitude 1500m Conditions for transport and storage Temperature 30 C to 70 C Humidity 95 non condensing Altitude 3500m Table A5 Environmental conditions ...

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Page 58: ...ize 0 4 in wall mount configuration with Extension arm where X 1 2 3 B2 Following standards under which conformity is declared ANSI AAMI ES 60601 1 A1 2012 C1 2009 R 2012 and A2 2010 R 2012 IEC 60601 1 ED 3 1 2012 CAN CSA C22 2 No 60601 1 14 IEC60601 1 2 2014 IEC 60601 1 3 2008 A1 2013 EN IEC 60601 2 65 2012 IEC60601 2 28 2010 CMDR SOR 98 282 B3 Marking The products described herein are conform to...

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Page 60: ...idance RF emissions IEC 60601 1 2 2014 CISPR 11 2010 EN55011 Group 1 Hatch X Ray uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions IEC 60601 1 2 2014 CISPR 11 2010 EN55011 Class A Hatch X Ray suitable for use in all establishments other than domestic establishments and those...

Page 61: ...ered with synthetic material the relative humidity should be at least 30 Electrical fast transient burst IEC 60601 1 2 2014 IEC61000 4 4 2012 2 kV for power supply lines 100kHz repetition frequency 1 kV for Signal lines 100kHz repetition frequency 2 kV for power supply lines 100kHz repetition frequency 1 kV for Signal lines 1 kV for Signal lines 100kHz repetition frequency Mains power quality shou...

Page 62: ...r quality should be that of a typical commercial or hospital environment If the user of the Hatch X Ray Variants requires continued operation during power mains interruptions it is recommended that the Hatch X Ray be powered from an uninterruptible power supply Power frequency 50 60 Hz magnetic field IEC 60601 1 2 2014 IEC 61000 4 8 2009 3 A m 50Hz OR 60Hz 3 A m 50Hz OR 60Hz Power frequency magnet...

Page 63: ...013 3V 6V 150 kHz to 80 MHz 3V 6V 150 kHz to 80 MHz Portable and mobile RF communications equipment should be used no closer to any part of the Hatch X Ray including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Where P is the maximum output power rating of the transmitter in watts W accor...

Page 64: ...opagation is affected by absorption and reflection from structures objects and people a 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 electroma...

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Page 66: ...HATCH X RAY Operating Manual 65 Hatch X Ray Hatch GROUP INC 4181 Sladeview Crescent Unit 36 Mississauga Ontario Canada L5L 5R2 Office Number 905 997 7171 ANNEX D CONTACT DETAILS ...

Page 67: ...OPERATING MANUAL PART NO 515 004627 0 REV 01 HATCH GROUP INC 4181 Sladeview Crescent Unit 36 Mississauga Ontario Canada L5L 5R2 ...

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