Instructions for using the CRT-2000
Contents
1. Eidam Diagnostics Corporation AAN cl Eidam Diagnostics Germany GmbH RK a f Ifa Io I R n CAN Richmond V6V 2X3 e D 35435 Wettenberg BIT c N CRT 2000 43 Temperatur Messf hler xxxx 97 U 06 0001 www eidam com DIAGNOSTICS CORPORATION SN Technical Specifications z Base Unit Label EJEidam Diagnostics Corporation Eidam Diagnostics Germany GmbH CAN Richmond V6V 2X3 e D 35435 Wettenberg TYPE CRT 2000 SN FDA 510K CE JE A973 177 imma Wie ma 10 240 inr WATT Environmental Temperatures Operating Temperature The CRT sensor will operate in temperatures between 10 C and 40 C If the CRT 2000 has been exposed to temperatures under 0 C an acclimitisation phase is necessary CRT Measurement Sessions are only valid when the room temperature is stable and between 20 C and 24 C Please refer to the Technician s Handbook for other measurement criteria Storage Temperature The CRT 2000 can be stored at temperatures between 20 and 60 C Electromagnetic Compatibility EMC Technical Specifications Electromagnetic compatibility with surrounding devices should be assessed when using the CRT 2000 An electronic device can either generate or receive electromagnetic interference Testing for electromagnetic compatibility EMC has been performed on the CRT 2000 according to the international standard for EMC for medical devices IEC 60601 1 2 This IEC standard has been adopted in Europe as the2. A This occurs when there is a significant software upgrade Please re enter the serial number from the left side panel of the CRT Core Unit Q How do I update my CRT to the latest software A Each time you restart the CRT software or send a Thermogram for analysis the CRT checks for software updates If there is a software update you will be prompted and guided through the automatic update process Q How do I back up my data A You can do this by clicking the Backup button from the Welcome screen or by manually copying the database file from the data directory to a backup device of your choice network memory stick or USB Hard Drive for example The database file resides by default in C Program Files Eidam Diagnostics Corporation CRT 2000 Thermographic System Data It is named either crt mdb or crt edb Q Can I export the Analysis Report A Yes from the Analysis Report tab click the Export Button You will be offered a variety of formats including Microsoft Word and Microsoft Excel Frequently Asked Questions 37 Frequently Asked Questions Q Can I read another practitioner s database A Yes Have them send you the database file from their Data directory Copy this into a new folder on your hard drive and open it from the Welcome screen by clicking File gt Open Q Can I share with another practitioner just one or a few records instead of my entire database A Absolutely From Patient Managemen
3. 2 Power Cables 1 for display 1 for Core Unit e VGA Video Cable e Mouse and Keyboard e Microsoft Windows XP License e Product Documentation Manual e Technician s Handbook 2 Connect the mouse and keyboard matching the color coded connectors to the Core Unit 3 Connect the CRT Sensor to the Core Unit by gently pressing the metal connector into the plug at the front of the CRT 2000 The connector is keyed such that the red dot faces up and matches the indentation on the connector See section below Sensor Connect the VGA Video Cable from the computer to the monitor Connect the supplied Power Cables from the computer and monitor to AC power 6 Connect the Internet as per your Internet Service Provider s instructions If you have high speed Internet such as a cable modem or ADSL you will need most likely need to connect their supplied Ethernet cable which looks similar to wide telephone connector to the matching receptacle at the back of the CRT Core Unit 7 Power onthe CRT Thermographic System by pressing the power switch on the front panel CRT2000 8 Run the CRT Sensor Self Test by pressing and holding the metal button on the sensor until hearing a double beep Please read the section Sensor for more information Cleaning Disinfection Turn off the unit and disconnect the power cable before cleaning The basic unit can be wiped carefully with a soft lint free cloth as needed Isopropyl Alc
4. European Norm EN 60601 1 2 The CRT 2000 should not be used adjacent to or stacked on top of other equipment If the CRT 2000 must be used adjacent to or stacked on top of other equipment verify that the CRT 2000 operates in an acceptable manner in the configuration in which it will be used The CRT 2000 will not malfunction when used with electrosurgical equipment Fixed portable and mobile radio frequency communications equipment can affect the performance of medical equipment see Table on page Error Bookmark not defined Reducing Electromagnetic Interference The CRT 2000 and accessories may become sensitive to interference from other RF energy sources including power lines RF energy sources include 32 other medical devices wireless devices information technology equipment and radio television transmission Should interference be encountered as demonstrated by releasing measurments without touching the skin or jitter on the screen attempt to locate the source by assessing e if the interference is intermittent or constant e does the interference occur only in certain locations e does the interference occur only when in close proximity to certain medical devices Once the source of the interference is located attempt to attenuate the EMC coupling path by distancing the CRT 2000 from the source of the interference as much as possible If further assistance is needed contact the Support of Eidam Ele
5. Initialize The CRT 2000 is now ready Errors in the Test Reading Procedure If the following information appears on the display screen after pressing the test button Test reading too low This may mean the Test Button was released before the second double beep Press the test button again and wait for the double beep If the measurement procedure starts automatically or the following message appears it is likely that the sensor is defective Please contact Eidam s Technical Support immediately Equipment Installation and Maintenance 15 Test reading too high Before the message Test Reading too low high is displayed the test reading measurement will be briefly displayed Please make note of this temperature reading and contact Eidam s Technical Support immediately Determining the Firmware Version The following message will appear briefly on the display screen if the test button is held down while the CRT 2000 is being powered up Version number and date are dependent upon the unit and version of the unit Version 41 4U of 27 09 2006 Equipment Installation and Maintenance 16 Software Documentation Starting the Software Welcome Screen Software Documentation Before running the CRT Measurement and Analysis Software ensure that the CRT Sensor has been connected properly and that an Internet connection is available Very Important An active Internet connection is needed to
6. leakage currents Type B applied part is isolated floating Type F Safety Instructions A Introduction The CRT 2000 Thermographic System is a medical device to be used exclusively for measuring temperatures on the patient s skin Any other use is strictly prohibited Under no circumstances should a user attempt to disassemble any part of the CRT 2000 including the sensor or to make alterations to the equipment Do not insert sensor into body cavities Inappropriate use storage or exertion of influence may lead to functional interference or damage of the equipment In case of smoke emission an abnormal smell or atypical sounds immediately power off the equipment and disconnect the power cable If there is condensation in or on the equipment do not use the equipment Condensation takes place in the form of water droplets or moisture for example exposing the equipment to extreme temperature variations can lead to operational disturbances or errors Disclaimer Introduction The science and medicine of contact regulation thermography are beyond the scope of this manual This manual details only the usage of the equipment and software not the interpretation of data or any scientific reasoning This information and any other information provided published or made available through Eidam Diagnostics Corporation is for educational or informational purposes only it is not intended to replace the services of a physic
7. operate the CRT 2000 Thermographic System Double click the CRT Icon on the Windows XP Desktop to start the software Once the software has successfully loaded the Eidam EasyStart screen will appear O un G Eidam EasyStart 8 Ei Tua Te atai madiing Lot iek han 1152005 EDIN ancora me marara er Lach kala Kam pror lech Ste of rea CAT u This indicates that the CRT Thermographic System has started and that the equipment has passed self tests To access different areas of software functionality click on the QuickStart Tasks to the left or on one of the Tabs above for instance Patient Management 17 Eidam EasyStart Software Documentation New Thermaogram Wizard This is a new patient Please start the New Patient Wizard This is a retuming patient Please help me identify the patient Last Name Name Birthdate Cancel Continue Eidam EasyStart allows a technician to easily add a new patient or access an existing patient For new patients the New Patient Questionnaire guides the technician through a series of questions to add the patient Ensure that the questionanaire is completed as accurately as possible For returning patients entering the last name will recall all patients whose last name matches any part of the search criteria For example Eldon will list Eldon Eldonson and Sheldon i New Patient Questionnaire 1 Patient 2 Contact 3 History 4 Start Patien
8. 0 Left Lower Jaw Current 33 00 Reference 33 50 Standard_D 10 Left Lower Jaw Currently measunng Rost Lehrbuch Session Started 9 13 2006 11 53 34 AM The left panel pictures a model showing the position of each measurement point The right panel contains a temperature graph showing the measured temperature of each point Above is the measurement point description Below the temperature graph is the progress of the measurement Click the toolbar button Begin Measuring Put the probe perpendicularly to the skin to measure the first reading point Glabella point The first beep indicates the beginning of the measurement The second beep indicates the end of reading double beep after Version 35 Remove the probe from the reading point To set up the reference value axis you need to measure the same point twice The difference between the readings must not exceed 0 1 C If the difference is higher repeat the procedure till the measurements do not exceed 0 1 C The first sets of readings are for dental readings The arrow buttons in the toolbar will now be activated Software Documentation 22 Software Documentation Finish Session WJ Pause Session Welcome Patient Management Measurement Session Analysis Session 3 8 lower jaw left Current 33 00 Reference 33 50 Standard_D 10 Left Lower Jaw Currently measuring Rost Lehrbuch Session Started 9 13 2006 11 53 34 AM The Measurem
9. 1 48 57 PM To take measurements 1 Touch the sensor to the patient s skin ensuring that it is perpendicular to the surface An audible beep will indicate that the sensor has made contact and a double beep follows shortly to indicate that a temperature reading has been taken successfully To set the reference temperature the first point must be re measured at least once The software will continue to ask that this point be re measured until there are two consecutive measurements with a temperature difference of 0 1 C or less this applies only to the first point Measure points as indicated by the visual guide to the left and detailed in the Technician s Handbook To re measure a point click on the left arrow in the toolbar For men the breast regions are optional Note for men click Begin Next Set of Measurements after the lower abdomen has been measured When all of the points of the First Reading have been measured a 10 minute timer will appear After 10 minutes have passed take the Second Reading re measure all of the points When all of the points have been measured a second time the measurement session is complete Note If the breast is not being measured click Finish Session button once the other points have been measured View the Results Eidam EasyStart Once the Measurement Session is complete the software opens Patient Management The Thermogram may now be viewed for analysis 1 Click
10. CRT 2000 THERMOGRAPHIC SYSTEM Product Manual M Eidam Leader in innovative health solutions CRT 2000 Thermographic System Product Manual rev 7 10 Copyright 2006 by Eidam Diagnostics Corporation All Rights Reserved No part of this work may be reproduced or transmitted in any form or by any means electronic or mechanical without the prior written permission of the copyright owner Trademarked names may appear in this book Rather than use a trademark symbol with every occurrence of a trademarked name we use the names only in an editorial fashion and to the benefit of the trademark owner with no intention of infringement of the trademark EIDAM Diagonstics Corporation 114 11120 Horseshoe Way Richmond BC V7A 5H7 Canada Tel 1 604 304 6006 Fax 1 604 304 6007 Toll Free North America 1 866 798 4CRT 4278 German Language 1 604 209 5085 Email info eidam com Internet www eidam com Contents Introduction 3 IOON ner ea ee ter an amen ener rere er tr mene een 3 Trademarks and other Information cccccccccccesseseeeeceeeeeeeeeeeeeeeeeesseaeeeeeesaeaeeeees 3 VIMO OS SCC nee ee ae 4 Safety Instructions uuessssnssssnnnnennnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn 4 PONS GAINS Wh as ee 5 Eidam EasyStart 6 INtLOdUENON une euere ee 6 EasyStart Welcome Screen uuuuuesssnnnennnnnnennnnnnnnnnnnnnennnnnnnnnnnnnnnnnnnnnnnnnnenennnnennnnn 6 New Thermogr
11. a ra wae PCA Sea btn me omy oe Bret paar a E ee a a a Tiea Marey Manan racic 32 en wre Tiny Werd ip ic ig oniy rk Da Cee panpa TM eet egos 3 ware AT Fite Bathenagatitry Feke i 00 Then Iren eher hraa ee ee En el which ingkcaten fray panda ed irapa Enge ibh ck rd ker The Lyonnais eiea im HC This ine reat rer are typhi ini aior fe bidid reeked ee vee kee eg aed a iry ier ge OF er ey The abc cree nice pres bey A barai poani cae by a eer eure De deren 4 0 Region Anabyals 411 Agden bead Dioual ony deer EM Hader Hani bic eng al rently Tipna Par the hasi Sanu ai Fib ai eg a WERDEN Ed Ga GT ee TE a BM This represents a standardized server based evaluation ofthe data Note that on the top right corner of the evaluation the report reads Analysis Version As new server interpretation methods become available it is possible to re submit data for evaluation Software Documentation 0 Technical Specifications General Electrical Safety This device conforms to the norm VDE 0750 IEC 601 1 Class with Measurement Function according to EC Directive 93 42 EWG Electromagnetic Compliance EMC according to EN 60601 1 2 and EN 794 3 Noise suppression EN 55011 Interference Resistance EN 61000 4 2to3 Temperature Measurement Measurement Range 26 0 C 38 0 C Measurement error 0 1 C when the Sensor tip is immersed in a water bath Sensor Label
12. am Wizard uuuussnesnnennnnnnnnnennnnnennnnnnnnnnnnnennnn nennen nnennnnnnnnnnne nenn 7 Performing the Measurement 2 24s00440440Rnennnnnnnnnnnnnennennennnn nennen nnennnn nennen 9 VIEW the Results unsern 10 Equipment Installation and Maintenance 11 Safety Inspection and Calibration 2222000000220000nnnnneeennnnnnnnnnnennnnnnnnnnnnnenn 11 Serial Number and License Information ccccccccssseeeeeeeeeeeeaeeeseeeeeeessaeaeseeeeees 11 Metala Otc achat a ne a ea ee ns nee 11 Cleaning DISINFECTION 00s2222224000000RRnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnennnnnnnnnnnn 12 Cleaning disinfection of the Sensor sssssnsssneneesnnnnnnnnnnnneennnnennnnnnn 13 Environmental Issues and Safe Disposal ccccccccsseeeeeeeeeeeeeeeeaaeeeeesessaaeeees 13 SEN S OF ee nee 13 REMOVING Ihe Senso anaana einen 13 Important Note for Use of the Sensor 2uuuussssnnnnnnnnnneennnnnnnnnnnnene nn 13 Sell ESE INSstruclonsaen ee 14 PEST REIN Area 15 Errors in the Test Reading Procedure ccccccssssececceeeseeeeeceeeeeeecssaeeeessssanseeess 15 Determining the Firmware Version cccccssccccsssececeeseeeceeeseeeceseeessseeeneneeesseass 16 Software Documentation 17 Staring the SOWA E srania een ma 17 WEIEOME Sereen anne eisen ie 17 E dam ears to hm ko Fae meee 2 ee 18 Managing Pallenls een ee 19 PAUCHL IS ee eek 19 Adding Deleting and Updating Patie
13. ateur radios AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the CRT 2000 is used exceeds the applicable RF compliance level above the CRT 2000 should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the CRT 2000 b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the CRT 2000 34 The CRT 2000 is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the CRT 2000 can help to prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the CRT 2000 as recommended below according to the maximum output power of the communications equipment Separation Distance According to Frequency of Transmitter m Output Power of 800 MHz to 2 5 GHz Transmitter W d 12 P d 2 3 P For transmitters rated at a maximum output power not listed above the recommended separation distance din meters m can be estimated using the equation appl
14. ation 3 Condition Please enter the following information Measurement Program Standard_D vi Operator Height cm Hip Size Weight kg Waist Size Blood Pressure Cycle Days Room Temp C 3 Each section must be completed in order to proceed Select Yes if any of the conditions for a section applies and check off specific conditions otherwise select No Complete this questionnaire as accurately as possible 1 Vital Statistics 2 Medication 3 Condition 4 Misc 5 Start ls this patient curently taking any medication Yes No Thyroid Medication E Hormones i Fat Bumer Birth Control F Cortisone 7 Chemotherapy Ld 4 Click OK Performing the Measurement A CRT Measurement Session consists of a First Reading during which the patient progressively disrobes a 10 minute cooling period followed by a Second Reading Each Reading consists of 119 Measurement Points Eidam EasyStart After completing the Session Questionnaire the Measurement screen will appear with a visual guide to the left and measurement data to the right ER E Fle Ml Finich Sesson i Pause Session fp Begn Next Setof Measurements 44 4 gt sragement Measurement Session alysis Se 3 8 lower jaw left BE Reference 33 5 Standard_D 10 Left Lower Jaw Currently measuring Mrac Vesna Sesson Started 3 29 2006
15. authorized CRT 2000 Service Centers These Inspections must be conducted by certified service personnel as improper inspections may fail to identify safety issues or damage the equipment and void product warranty Appropriate measurement and testing equipment are necessary for conducting the tests The accuracy of the metrological equipment and test environment must be a minimum of three times the specification accuracy of the device under test Metrological testing to assess the maximum error must be conducted by qualified personnel in line with the regulations of the country within which the equipment is used Eidam at a minimum uses German regulations as its benchmark for such requirements and as such follows the Guide to metrological controls of medical devices having a measurement function published by Physikalisch Technischen Bundesanstalt Germany current revision 6 September 2001 In Germany Persons conducting a metrological inspection must report this to the responsible bureau before beginning the inspection 11 Nr 5 MPBetreibV Eidam s authorized service centers will complete these tests free of charge for product covered under Eidam s warranty or service agreement 36 Frequently Asked Questions CRT 2000 Frequently Asked Questions Q The software says that the server doesn t recognize my client license information When I click Retry it shows my customer ID as 000000 What do do
16. ccsceceeecseeeeeeseeeeeeseeees Device Safety Inspection nenioo ei Metrological Inspection ana Frequently Asked Questions CRT 2000 Frequently Asked Questions ccccccceseeeeeeeeeeeeees Appendix GIOSSANY er nl Support Technical SUpporta a eatiuautagusede dianetoaenumanes Instructions for using the CRT 2000 Contents e ii Introduction Important Please read the entire Product Manual before using the equipment This Product Manual describes the installation usage and maintenance of the CRT 2000 Thermographic System It is complemented by the CRT 2000 Technicians Handbook which provides additional details for conducting a CRT exam Trademarks and other Information All company product and trade names referred to in this manual are trademarks of their respective companies Eidam and CRT 2000 are registered trademarks of Eidam Diagnostics Corporation Microsoft and Windows are registered trademarks of Microsoft Corporation Introduction 3 Symbols Used C E xxxx This product conforms to the EC Directive for medical products 93 42 EWG N Please read user manual before starting IPXO The device is not water resistant mil Manufacturer symbol Applied Part Type BF1 Device Number SN xx v yy zzzz xx v internal code number for product type and version yy Production Year zzzz Serial Number Applied part warrants protection against electric shock through norm conform restriction of
17. ctromagentic Emissions Guidance and Manufacturer s Declaration Electromagentic Emissions The CRT 2000 is intended for use in the electromagnetic environment specified in the table below The customer or the user of the CRT 2000 should assure that it is used in such an environment RF Emissions Group 1 The CRT 2000 uses RF energy only for its internal function CISPR 11 Therefore its RF emissions are very low are not likely to cause any interference in nearby electronic equipment RF Emissions Class B The CRT 2000 is suitable for use in all establishments CISPR 11 including domestic establishments and those directly connected to the public low voltage power supply network Harmonic Emissions Class D that supplies buildings used for domestic purposes IEC 61000 3 2 Voltage fluctuations Complies flicker emissions IEC 61000 3 3 Electromagnetic Immunity Guidance and Manufacturer s Declaration Electromagnetic Immunity The CRT 2000 is intended for use in the electromagnetic environment specified in the table below The customer or the user of the CRT 2000 should assure that it is used in such an environment Emissions Test Compliance Compliance Level Electromagnetic Environment guidance Electrostatic 6 kV contact Complies Floors should be wood concrete or Discharge ESD 8 kV air ceramic tile If floors are covered with IEC 61000 4 2 synthetic material the relative humidity should be at
18. easurement in the Thermogram the corresponding point description will be displayed LI I TI E v7 SS a ee ee Measurement Point Details Data Point 18 Point Name Wisdom tooth Bu oe Be Sensory Organ Inner ear maxillary sinus Yin Organs Heart Musculature Trunk lower amp upper extremities musculature Yang Organs Duodenum RM Segments C VIL ThI Y YI VIL S 1 I amp I Vertibrae CYI THLYRYLSTR I Joints Shoulder elbow ulnar hand plantar foot toes sacro iliac joint Endocrine Glands Pituitary anterior lobe ja Meridian Small intestine Tendencies Central Nervous System mind controls psycho vegetative state weather sensitivity weather induced hemicrania vegetative dystonia cerebral spasms central amp peripheral defunctionalization phenomena epilepsy sensory amp motor disorders MS brain spinal tumor vitality disorders aphonia after extended talking sciatica migraine headache tinnitus periarthritis humeroscapularis nocturnal brachialgia generally upper extremities hand eczema skin problem face hand edema trigeminus neuralgia neuritis 4371 54 B2 1123432312732 755 4 GNANARBAS KT B E ee ee gt ee ee 8 9 10 12384 15 16 7 18 9 DD 1234 35733312 DM 5 SS 73 I 22 12 9 4 Software Documentation 29 Analysis Report Once a Thermogram has been opened the fifth tab Analysis Report is available This opens the server based evaluation RT COMA TI 10 nih rey Form
19. ent Session tab shown above will display during a measurement session This tab will show reading position with its assignment points along with the numbers and positions of the points in the current set of readings The thermogram of the current set of readings will also be on display Finish Session ll Pause Session amp Begin Next Set of Measurements Clicking on one of the arrows on the toolbar selects the current measure point For example if a point was measured incorrectly the back arrow may be clicked to re measure this point Clicking on one of the double arrows 4 or PP moves the current point to the previous or next measurement area When all measurements have been taken click on Finish Session Pause Session stops the sensor temporarily from taking measurements To resume the measurement session click on Begin Measurement Begin Next Set of Measurements ends the current set of measurements and begins the next set of measurements When a new Measurement Set is started a timer window will open Regulation Timer Current time 11 59 23 Software Documentation A measurement session consists at least two sets The first Measurement Set is charted with black bars The second set is charted with red bars On CRT units supporting a third or fourth measurement the third set will be charted in green and a fourth set is charted with blue bars The preview button on the timer window gives a preview of the t
20. hermogram The skip button once clicked will skip the 10 minute timer altogether 24 Software Documentation The illustration below shows the second reading in progress Eidam Diagnostics Corporation CRT 2000 File Tools I Finish Session Il Pause Session 4 4 bh LL Preview Welcome Patient Management Measurement Session Analysis Session Analysis Report T 2 tonsil left 2 3 4 5 6 7 G 9 10 11 R 13 Measurement Recorded 32 9 Current 32 90 Reference 33 50 Standard_D 2 Neck Currently measuring Rost Lehrbuch Session Started 9 13 2006 11 53 34 AM After completion of the second measurement the following dialog window appears Session Complete This measurement session is now complete Do you wish to sawe this session Once you click Yes and continue you will not be able to return to re measure points From this session Clicking on Yes will complete the measurement and will save the data Clicking on No will allow measurement points to be re measured Submitting Session for Analysis Once the measurement session is complete the software returns to Patient Management screen The session information in the patient records list will now look like this Welcome Patient Management Measurement Sessions a Thermogram session ID session Date Prograrn Smith John To send the session to the Server for analysis click Load Analysis on the Toolbar The following window prompt will di
21. ian or other accredited health care provider or to be or actas a substitute for professional medical advice care or treatment You should not rely on or use any such information for determining the state of your health for diagnosing or treating a medical or health condition or as a substitute for personal medical attention diagnosis or hands on treatment You should consult a physician in all matters relating to your health and particularly in respect to any symptoms that may require diagnosis or medical attention Eidam Diagnostics Corporation makes no representations or warranties with respect to any information provided published or made available through the CRT 2000 Thermographic System and is not liable for any direct or indirect claim loss or damage resulting from use of or reliance on any information provided published or made available through Eidam Diagnostics Corporation or the CRT 2000 Thermographic System Eidam EasyStart Introduction This tutorial describes the process of adding a patient taking a measurement and viewing a Thermogram It also explains some of the basic terminology specific to the CRT 2000 Before beginning ensure that the probe is connected and that an internet connection is active With the CRT turned on press and hold the CRT Sensor test button for four seconds You will hear a beep followed by a double beep and the LCD display on the front of the CRT will read Waiting to Initia
22. icable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Note At 80 MHz and 800 MHz the separation distance for the higher frequency range applies Note2 These guidelines may not apply in all situations Electromagnetic propagation is affected by the absorption and reflection from structures objects and people Rated Maximum Device Safety Inspection Eidam recommends that safety and functional inspections of the CRT 2000 Thermographic System be performed only by Eidam authorized CRT 2000 Service Centers These Inspections must be conducted by certified service personnel as improper inspections may fail to identify safety issues or damage the equipment and void product warranty The Safety Inspection is a mandatory part of every service cycle It Includes e Complete visual inspection e Equipment Grounding Conductor Test DIN EN 60601 1 1990 e Leakage Current Measurement Test DIN EN 60601 1 1990 e Functional Test Eidam s authorized service centers will complete these tests free of charge for product under Eidam s warranty or service agreement Technical Specifications 35 Metrological Inspection Technical Specifications This inspection ensures that the CRT Sensor is operating within its specification Eidam recommends that Metrological Inspections of the CRT 2000 Thermographic System be performed only by Eidam
23. id areas The Fine Gridlines turns on or off additional higher resolution gridlines The following illustration demonstrates the Thermogram display with the following options selected Zoom Level 2 Bottom Thermogram only Plot Normal Value as Line and Fine Gridlines enabled u Zoom Normal Value 2 Fine Gridlines Plot Normal value a5 Grea Plot Normal value as Line a Software Documentation 27 Other Toolbar Functions I Indices Patient Data Point Descriptions Indices Will open the Session Information Window shown below Session Information Thermographic Indices Cl Head Cl Body Wi EA A Thermal Overview Patient Data Opens a window with four tabs displaying patient information Personal information medical history with comments measurements taken questions related to complaints and or pathological symptoms Software Documentation 28 Patient Information Fabsent Information cal ese e ee TEE Prov State Country Tel Home Fax Tel Work FeRe EEE EEE FEFeEE EERE F Patient Information Session Date 2 12 2006 10 24 Measurement Program Standard _D Operator cm Hip Sie 106 kg Waist Size 6 Point Descriptions opens a pop up window displaying Measurement Point Details If the cursor is placed over a m
24. ile Tools Search For Last Name 5 First Name Telephone Session Date Show All Welcome Patient Management To find an existing patient you can use the Search function in the toolbar Select a search type in the dropdown enter criteria to narrow the search and then click on Filter to search the patient database Software Documentation 20 Entering Measurement Data Adding a New Measurement To begin a new Measurement Session select a customer and then click on the New Session icon in the Toolbar The following wizard will appear guiding you through the process 1 Vital Statistics 2 Medication 3 Condition 5 Start Please enter the following information Measurement Program Standard_D 7 Operator Height cm Hip Size Weight ka l Waist Size Blood Pressure Cycle Days Room Temp C Some of the fields are required If you miss one of these fields the CRT will advise you with a 3 symbol Follow the wizard and which will take you to the measurement process Note Two measurement programs are available 1 Standard D Program for adults 2 Child D Program for children Software Documentation 21 Taking measurements Once the questionnaire has been completed the following screen will appear Be Begin Measurement Set 44 4 gt PP Preview atient Management Measurement Session Analysis Session 3 8 lower jaw left 1
25. is located on the front left of the CRT Core Unit CRT Display This refers to the widescreen display CRT Measurement and Analysis Software The CRT Measurement and Analysis Software is the software program that is controls the CRT Thermographic System allowing you to take measurements and read results CRT Sensor This is the measurement probe included with the CRT 2000 Thermographic system It must be calibrated regularly Measurement Session This refers to a measurement session which includes the recording of a patient s personal data and history their first reading a cooling period and their second reading Measurement Set Each Measurement Session contains at least two sets of measurements These are each referred to as a Measurement Set 39 Support Technical Support For technical support please contact Eidam Diagnostics International EIDAM Diagonstics Corporation 114 11120 Horseshoe Way Richmond BC V7A 5H7 Canada Tel 1 604 304 6006 Fax 1 604 304 6007 Toll Free North America 1 866 798 4CRT 4278 German Language 1 604 209 5085 Email info eidam com Internet www eidam com E AA eidam DIAGNOSTICS CORPORATION 140 11120 Horseshoe Way Richmond BC V7A 5H7 Canada Tel 1 604 304 6006 Fax 1 604 304 6007 info eidam com www eidam com 2006 Eidam Diagnostics Corporation
26. least 30 Electrical Fast 2 kV for power Complies Mains power quality should be that of transient burst supply line a typical commercial or hospital IEC 61000 4 4 1 kV for environment input output lines Surge 1 kV differential Complies Mains power quality should be that of IEC 61000 4 5 mode a typical commercial or hospital 2 kV common mode environment Voltage dips short lt 5 Ur Complies Mains power quality should be that of interruptions and gt 95 dip in Ur a typical commercial or hospital voltage variations on for 0 5 cycle environment If the user of the CRT 2000 required continued operation power supply input lines 40 Ur 60 dip in Ur during power mains interruptions and to avoid loss of data it is Technical Specifications Technical Specifications IEC 61000 4 11 for 5 cycles recommended that the CRT 2000 be 70 Ur powered from an uninterruptable 30 dip in U power supply for 25 cycles lt 5 Ur gt 95 dip in Ur 5 seconds Power frequency 3 A m Complies Power frequency magnetic fields 50 60 Hz magnetic should be at levels characteristic of a field typical location in a typical commercial IEC 61000 4 8 or hospital environment Note UT is the a c mains voltage prior to application of the test level Guidance and Manufacturer s Declaration Electromagnetic Immunity The CRT 2000 is intended for use in the electromagnetic environment specified in the
27. lize The CRT is now ready for use Start the CRT software by double clicking the program icon on the desktop EasyStart Welcome Screen Eidam EasyStart The Eidam EasyStart welcome screen simplifies the process of working with patients and conducting CRT sessions The welcome screen also identifies any new updates and Customer Support site additions available for download To start a Thermogram for a new or returning patient click on the EasyStart icon on the sidebar New Thermogram Wizard New Themogram Wizard This is a new patient Please start the New Patient Wizard This is a retuming patient Please help me identify the patient Continue The New Thermogram Wizard allows a technician to easily add a new patient or access an exiting patient For this tutorial select This is a new patient and then click Continue A New Patient Questionnaire window will appear i New Patient Questionnaire 1 Patient 2 Contact 3 History 4 Start Patient Last Name Male Female First Name Address Address City Complete each tab of the Patient Questionnaire taking care to complete the patient history as accurately as possible Eidam EasyStart 7 Eidam EasyStart Once the Patient Questionnaire has been completed the New Session Questionnaire window will automatically start 1 Complete the Session Questionnaire 1 Vital Statistics 2 Medic
28. nt uuss2202400000Rnennnn ee nnnnnee nenn 20 Add a New Paten tice es kee eae eee 20 Entering Fr alent ala ssia 20 Update Patient Dala reien ee 20 Deleting a Patient or Measurement Session ccccseeeeeceeeeeeeeeeeeeeaees 20 FINANG a PAUEeNnL e ie re ee nase 20 Entering Measurement Data u222242022200000000nnn nennen nnnnnnnnnnnnn nennen nennen nennen 21 Adding a New Measuremernt s04422440000002000neRnnnnnnn nennen nennen 21 Taking measlrements zusehen 22 Instructions for using the CRT 2000 Contents ei Submitting Session for Analysis cccccccseeeeeeeeeeeeeees Inermogram Analysis na Inermo gram Displav ch na a Functions for use with the Thermogram Display Other Toolbar FUNCTIONS ccccececcececcececcececcececeecess PMAIV SIS ReBOrl n eicitunne sein Technical Specifications COINS I all orrua an eae ence inact toadside N Temperature Measurement ccccccccsseeseeeeeeeeeeeeeeeseeeeeeesuaeeeees Sensor labels BasellAitEabeln an a Arie Environmental Temperatures 4uu00444nne nennen nennen nennen Operating Temperature uuuesssssssesnnnnneennnnnnnnnnnneenen Storage Temperatueren Electromagnetic Compatibility EMC sss2202220ueeeenneeenn Reducing Electromagnetic Interference Electromagentic EMISSIONS cccccesseeeeeeeeseeeeneeees Electromagnetic IMMUNIY c
29. ohol may be applied to a cloth Do not use abrasive detergents aggressive cleaning agents such as acetone as this will damage the polymer coatings Equipment Installation and Maintenance 12 Very Important Water must not enter the unit Cleaning disinfection of the Sensor The sensor should be carefully wiped with a soft lint free cloth as required Soft cleaning detergents such as a gentle dishwashing soap may be used Do not use abrasive detergents aggressive cleaning agents this will damage the polymer coatings Should any liquids enter the sensor allow at least 2 hours time for the sensor to dry completely You can sterilize the sensor tip by immersing it for maximum one centimeter into a container of non aggressive disinfecting agent ie 70 Alcohol 0 5 Chlorhexidin and water Standard disinfecting agents are too aggressive and may dissolve the mesh at the tip of the sensor Allow several minutes time for the sensor to dry completely before reusing it The sensor cannot be autoclaved or sterilized with hot air Environmental Issues and Safe Disposal Sensor All components of the equipment described including the packaging are designed to maintain a high degree of environmental friendliness All parts of the described device can be separated and recycled or correctly disposed of by companies offering special waste disposal services Defective products or products no longer used can be returned to the manufac
30. on the session that was just recorded at the top of the Patient List to the left Click Load Analysis Click OK to send the session to Eidam Servers for analysis The Thermogram will automatically load once the analysis is complete 5 To view the detailed Analysis Report click on the Analysis Report tab This concludes the CRT EasyStart Tutorial 10 Equipment Installation and Maintenance Safety Inspection and Calibration The CRT 2000 Sensor must be calibrated at least every two years to ensure device accuracy The sensor must be calibrated by an Eidam Technical Support Centre Please refer to the Technical Support section of this manual to locate a service centre near you Serial Number and License Information All licensing and serial number information is affixed on a label on the left panel of the CRT Core Unit In some cases such as a software upgrade you may need to re enter this information Installation The CRT 2000 ships with Microsoft Windows XP and the CRT 2000 Measurement and Analysis Software preconfigured If you are unfamiliar with connecting computer equipment please call Eidam technical support To connect the CRT 2000 follow these steps 1 Unpack the two boxes containing the CRT Thermographic System They should include e CRT 2000 Thermographic System Core Unit e CRT Skin Surface Temperature Sensor Equipment Installation and Maintenance 11 e CRT 19 Widescreen LCD Display e
31. splay 25 Server Analysis The CAT is ready to send a thermogram to Eidam Diagnostic s servers Personal Information about the patient such as the patient s name address and contact Information will not be transmitted Do you wish to proceed After the server analysis is complete the software will open to Thermogram Analysis Thermogram Analysis Body Anatysts Readings 17 Dem al Mamma Anatyses Be edings 12 Reaction Prarke Meek 2 12 2006 10 20 34 am Evaluaters 1 20 3 78 2006 9 35 16 AM This screen contains all of the measurement data and calculated indices necessary to perform an analysis of the patient The Thermogram Analysis tab contains two panels 1 The Reaction Profile above 2 The Thermogram Display below Software Documentation 26 Thermogram Display The Thermogram is divided into the following areas Upper Thermogram Lower Thermogram 1 Head 7 Right Upper Jaw 2 Neck 8 Left Upper Jaw 3 Chest 9 Right Lower Jaw 4 Upper Abdomen 10 Left Lower Jaw 5 Lower Abdomen 11 Right Mamma 6 Back 12 Left Mamma Functions for use with the Thermogram Display Toolbar functions change the appearance of the Thermogram Zoom Normal value _ 4 Fine Gridlines The Zoom function is a drop down menu and allows for enlarged viewing of a portion of the Thermogram The Normal Value drop down on the toolbar toggles the shaded yellow area between lines and sol
32. t Last Name Male Female First Name Address Address City 18 Managing Patients Software Documentation a Eidam apostes Corporation CHI wih Anihia ethan Andie Renon uerai 9 uesa Uele Kirwie Vina Penne Russell Tau Anita He Uric Levee HOTO Wee AN irete Chris tre IHA JATO 557 08 AN Sacdard De Dni the information for the 100 patents most recently undated se darimed To beer a ale eerie ei a pale Been dick Lie Anaya The Patient Management tab is divided into two panels the Patient List on the left and the Patient Information Panel on the right Patient List The list of patients names records of their measurements sessions in date order Patient Information Panel Patient personal information including health records are displayed here Patient List This window lists patients and measurement sessions recorded There are five parameters for obtaining useful patient information about the sessions Session ID Shown in this column is the ID number given to each measurement session Session Date The date and time of the measurement session Program The program which was used for the measurement The number of measurements conducted in the session A Acolumn consisting of a single checkbox for each measurement session Black colored checkbox shows the session data has already been anal
33. t select a session and click File Export Follow the dialog box and an XML file will be created that will allow another CRT 2000 owner to open it by selecting File Import from their Patient Management screen Q How can I delete a patient who has session data A If you truly wish to delete the patient you will need to first delete all of their measurement sessions Q How do I resubmit measurement data to the server A From the Patient Management screen select a measurement session right click and then left click Resubmit Session Q How do l install a printer A Copy all printer drivers from the CD that came with the printer to a USB memory key Insert the USB memory key into an available USB slot on your CRT 2000 Core Unit and install printer drivers as per the instructions provided with your printer You may also choose to download the driver files from the printer manufacturer s website and install it directly on the CRT 2000 Core u 38 Appendix Glossary Glossary CRT 2000 Thermographic System The CRT 2000 Thermographic System includes the CRT Core Unit CRT Sensor CRT Display CRT Measurement and Analysis Software and CRT Server based analysis service CRT Core Unit This is the computer system to which the CRT Sensor and Display connect to It must be calibrated and checked for safety regularly CRT Core Unit LCD The CRT Core Unit LCD is the small backlit LCD that displays sensor status It
34. table below The customer or the user of the CRT 2000 should assure that it is used in such an environment Emissions Test Compliance Compliance Level Electromagnetic Environment guidance Conducted RF 3 Ver Complies Portable and mobile RF communi IEC 61000 4 6 150 kHz to 80 MHz cations equipment should be used no closer to any part of the CRT 2000 Radiated RF 3 V m Complies including cables than the IEC 61000 4 3 80 MHz to 2 5 GHz recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance 2 ye 80MHz to 800MHz m iz P 800MHz to 2 5GHz 3V m Where Pis the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and dis the recommended separation distance in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol gt Note1 At 80 MHz and 800 MHz the higher frequency range applies Note2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from surfaces objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios am
35. turer for disposal The sensor is connected to the main unit with a special 7 pin plug To connect the sensor find the red alignment marking on the 7 pin connector Face the red alignment dot in the same direction as the notch on the connector and gently insert Removing the Sensor To disconnect the sensor from the CRT 2000 pull the ribbed cover on the connector back The connector will unlock allowing the sensor to be removed Important Note for Use of the Sensor While the sensor is in contact with the patient do not move the sensor ina side to side motion Doing so may damage the sensor Equipment Installation and Maintenance 13 Self Test Instructions When the CRT Core Unit is powered up the following messages will appear on the CRT Core Unit LCD CRT2000 Eidam Diagnostics Corporation 88 8 C Equipment Installation and Maintenance 14 Test Reading Once the above internal checks have been successfully completed the following message will appear on the display screen Please press the test button Press the silver test button on the back of the sensor Do not release the button until you have heard the second double beep A successful test reading is indicated by the following message on the display screen 34 2 C and 34 4 C are acceptable test readings also 34 3 C Test reading O k The above information will appear on the display after a brief pause followed by Waiting to
36. yzed by the server and the Thermogram and analysis report are available to be viewed A blank checkbox indicates the data has not yet been sent to the server for analysis Clicking on a session gives information about the patient in the Patient Information Panel 19 Adding Deleting and Updating Patients Add a New Patient To add a new patient click New Patient on the Toolbar In the popup window fill out the patient s first and last name then click OK Entering Patient Data The Patient Information window contains the patient s personal information medical history and the physician s notes To save changes click Save Patient on the toolbar Ifthe amp symbol appears a required field has been omitted Update Patient Data To update an existing patient first click on any entry below their name in the Patient List Deleting a Patient or Measurement Session Patients can only be deleted if they have no measurement data Delete a patient by right clicking the row underneath the patient s name reading None and then left clicking Delete Patient To delete a patient who has measurement sessions you must first delete all associated measurement sessions by right clicking the measurement session and left clicking Delete Session Deleting a patient or measurement session is a permanent operation and cannot be reversed Finding a Patient SE Eidam Diagnostics Corporation CRT 2000 MostRecent FA F
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