Instructions for using the CRT-2000

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:
Internet:
info@eidam.com
www.eidam.com
Contents
Introduction
3
Important ................................................................................................................. 3
Trademarks and other Information.......................................................................... 3
Symbols Used ......................................................................................................... 4
Safety Instructions .................................................................................................. 4
Disclaimer ............................................................................................................... 5
Eidam EasyStart
6
Introduction ............................................................................................................. 6
EasyStart Welcome Screen .................................................................................... 6
New Thermogram Wizard ....................................................................................... 7
Performing the Measurement ................................................................................. 9
View the Results ................................................................................................... 10
Equipment Installation and Maintenance
11
Safety Inspection and Calibration ......................................................................... 11
Serial Number and License Information ............................................................... 11
Installation ............................................................................................................. 11
Cleaning / Disinfection .......................................................................................... 12
Cleaning / disinfection of the Sensor: ...................................................... 13
Environmental Issues and Safe Disposal ............................................................. 13
Sensor ................................................................................................................... 13
Removing the Sensor: ............................................................................. 13
Important Note for Use of the Sensor: ..................................................... 13
Self Test Instructions ............................................................................................ 14
Test Reading ......................................................................................................... 15
Errors in the Test Reading Procedure .................................................................. 15
Determining the Firmware Version ....................................................................... 16
Software Documentation
17
Starting the Software ............................................................................................ 17
Welcome Screen ................................................................................................... 17
Eidam EasyStart ................................................................................................... 18
Managing Patients ................................................................................................ 19
Patient List ............................................................................................... 19
Adding, Deleting, and Updating Patients .............................................................. 20
Add a New Patient ................................................................................... 20
Entering Patient Data ............................................................................... 20
Update Patient Data................................................................................. 20
Deleting a Patient or Measurement Session ........................................... 20
Finding a Patient ................................................................................................... 20
Entering Measurement Data ................................................................................. 21
Adding a New Measurement.................................................................... 21
Taking measurements .......................................................................................... 22
Instructions for using the CRT-2000
Contents • i
Submitting Session for Analysis .............................................................. 25
Thermogram Analysis ........................................................................................... 26
Thermogram Display ............................................................................................. 27
Functions for use with the Thermogram Display ..................................... 27
Other Toolbar Functions .......................................................................... 28
Analysis Report ..................................................................................................... 30
Technical Specifications
31
General ................................................................................................................. 31
Temperature Measurement .................................................................................. 31
Sensor Label ......................................................................................................... 31
Base Unit Label ..................................................................................................... 32
Environmental Temperatures................................................................................ 32
Operating Temperature............................................................................ 32
Storage Temperature ............................................................................... 32
Electromagnetic Compatibility (EMC) ................................................................... 32
Reducing Electromagnetic Interference ................................................... 33
Electromagentic Emissions ...................................................................... 33
Electromagnetic Immunity........................................................................ 33
Device Safety Inspection ...................................................................................... 35
Metrological Inspection ......................................................................................... 36
Frequently Asked Questions
37
CRT 2000 Frequently Asked Questions ............................................................... 37
Appendix
39
Glossary ................................................................................................................ 39
Support
40
Technical Support ................................................................................................. 40
Instructions for using the CRT-2000
Contents • 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® Technician’s 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
XXXX
This product conforms to the EC-Directive for medical
products. (93/42/EWG).
Please read user manual before starting
IPX0
The device is not water resistant.
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
1
Applied part warrants protection against electric shock through norm-conform restriction of
leakage currents (Type B); applied part is isolated (floating) (Type F)
Safety Instructions
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.
Introduction
4
Disclaimer
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
physician or other accredited health-care provider, or to be or act as 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.
Introduction
5
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 Initialize”. The CRT is
now ready for use.
Start the CRT software by double-clicking the program icon on the desktop.
EasyStart Welcome Screen
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.
Eidam EasyStart
6
New Thermogram Wizard
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.
Complete each tab of the Patient Questionnaire, taking care to complete the
patient history as accurately as possible.
Eidam EasyStart
7
Once the Patient Questionnaire has been completed, the New Session
Questionnaire window will automatically start.
1. Complete the Session Questionnaire.
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.
4. Click OK.
Eidam EasyStart
8
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.
After completing the Session Questionnaire, the Measurement screen will
appear, with a visual guide to the left, and measurement data to the right.
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.
2. To set the reference temperature, the first point must be remeasured 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).
3. Measure points as indicated by the visual guide to the left, and
detailed in the Technician’s Handbook.
4. To re-measure a point, click on the left arrow in the toolbar.
5. For men, the breast regions are optional.
Note: for men, click Begin Next Set of Measurements after the
lower abdomen has been measured.
6. 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).
7. 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.
Eidam EasyStart
9
View the Results
Once the Measurement Session is complete, the software opens Patient
Management. The Thermogram may now be viewed for analysis:
1. Click on the session that was just recorded, at the top of the
Patient List to the left.
2. Click Load Analysis.
3. Click OK to send the session to Eidam Servers for analysis.
4. 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.
Eidam EasyStart
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:
Equipment Installation and Maintenance
•
CRT 2000® Thermographic System Core Unit
•
CRT Skin Surface Temperature Sensor
11
•
CRT 19” Widescreen LCD Display
•
2 Power Cables (1 for display, 1 for Core Unit)
•
VGA Video Cable
•
Mouse and Keyboard
•
Microsoft Windows XP License
•
Product Documentation Manual
•
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).
4. Connect the VGA Video Cable from the computer to the monitor.
5. 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 on the CRT Thermographic System by pressing the power
switch on the front panel.
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 Alcohol 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
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 manufacturer for disposal.
Sensor
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 in a
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
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
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 operate the
CRT 2000® Thermographic System
Double click the CRT Icon on the Windows XP Desktop to start the
software.
Welcome Screen
Once the software has successfully loaded, the Eidam EasyStart screen will
appear:
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).
Software Documentation
17
Eidam EasyStart
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.
Software Documentation
18
Managing Patients
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: A column consisting of a single checkbox for each measurement session.
Black colored checkbox shows the session data has already been analyzed
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.
Software Documentation
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.
If the
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
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:
Some of the fields are required. If you miss one of these fields, the CRT will
advise you with a
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:
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
The screen display is as below:
The Measurement 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.
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 (
or
) 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.
Software Documentation
23
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 thermogram.
The skip button, once clicked, will skip the 10 minute timer altogether.
Software Documentation
24
The illustration below shows the second reading in progress:
After completion of the second measurement the following dialog window
appears:
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:
To send the session to the Server for analysis, click Load Analysis on the
Toolbar.
The following window prompt will display:
Software Documentation
25
After the server analysis is complete, the software will open to Thermogram
Analysis.
Thermogram Analysis
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:
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 solid 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:
Software Documentation
27
Other Toolbar Functions
Indices: Will open the Session Information Window shown below:
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
Point Descriptions: opens a pop-up window displaying Measurement Point
Details. If the cursor is placed over a measurement in the Thermogram, the
corresponding point description will be displayed
Software Documentation
29
Analysis Report
Once a Thermogram has been opened, the fifth tab, Analysis Report is
available. This opens the server-based evaluation:
This represents a standardized, server-based evaluation of the 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
30
Technical Specifications
General
Weight:
8 kg
Dimensions:
105 x 325 x 430 mm
Voltage Input:
100 - 240 V AC +/- 10 %
Power Consumption:
180VA
Electrical Safety
This device conforms to the norm:
VDE 0750, IEC 601-1
Class I with Measurement Function according to
EC-Directive 93/42/EWG
Electromagnetic
Compliance (EMC)
according to EN 60601-12 and EN 794-3:
– Noise suppression
EN 55011
– Interference Resistance EN 61000 – 4 – 2 to 3
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
Eidam Diagnostics Corporation
Eidam Diagnostics Germany GmbH
CAN Richmond, V6V 2X3 • D-35435 Wettenberg
CRT 2000
Temperatur Messfühler xxxx
SN.
97.U.06.0001
www.eidam.com
Technical Specifications
31
Base Unit Label
Eidam Diagnostics Corporation
Eidam Diagnostics Germany GmbH
CAN Richmond, V6V 2X3 • D-35435 Wettenberg
TYPE
CRT 2000
SN.
18.P.06.0001
FDA 510K
K971956
XXXX
FDA Listing#
A973-177
VOLT 110-240~ Hz 50/60 WATT 180
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)
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 the 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
Technical Specifications
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:
•
if the interference is intermittent or constant?
•
does the interference occur only in certain locations?
•
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.
Electromagentic 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.
Emissions Test
Compliance
Electromagnetic Environment: guidance
RF Emissions
CISPR 11
Group 1
The CRT 2000® uses RF energy only for its internal function.
Therefore, its RF emissions are very low are not likely to
cause any interference in nearby electronic equipment.
RF Emissions
CISPR 11
Class B
Harmonic Emissions
IEC 61000-3-2
Class D
The CRT 2000® is suitable for use in all establishments,
including domestic establishments and those directly
connected to the public low-voltage power supply network
that supplies buildings used for domestic purposes.
Voltage fluctuations /
flicker emissions
IEC 61000-3-3
Complies
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.
Technical Specifications
Emissions Test
Compliance
Compliance Level
Electromagnetic Environment:
guidance
Electrostatic
Discharge (ESD)
IEC 61000-4-2
+/- 6 kV contact
+/- 8 kV air
Complies
Floors should be wood, concrete, or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30%.
Electrical Fast
transient/burst
IEC 61000-4-4
+/- 2 kV for power
supply line
+/- 1 kV for
input/output lines
Complies
Mains power quality should be that of
a typical commercial or hospital
environment.
Surge
IEC 61000-4-5
+/- 1 kV differential
mode
+/-2 kV common mode
Complies
Mains power quality should be that of
a typical commercial or hospital
environment.
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines
< 5% UT
Complies
Mains power quality should be that of
a typical commercial or hospital
environment. If the user of the CRT
2000® required continued operation
during power mains interruptions and
to avoid loss of data, it is
(>95% dip in UT)
for 0,5 cycle
40% UT
(60% dip in UT)
33
IEC 61000-4-11
recommended that the CRT 2000® be
powered from an uninterruptable
power supply.
for 5 cycles
70% UT
(30% dip in UT)
for 25 cycles
< 5% UT
(>95% dip in UT
for 5 seconds
Power frequency
(50./60 Hz) magnetic
field
IEC 61000-4-8
3 A/m
Complies
Power frequency magnetic fields
should be at levels characteristic of a
typical location in a typical commercial
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
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
IEC 61000-4-6
3 Veff
150 kHz to 80 MHz
Complies
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2,5 GHz
Complies
Portable and mobile RF communications equipment should be used no
closer to any part of the CRT 2000®,
including cables, than the
recommended separation distance
calculated from the equation
applicable to the frequency of the
transmitter.
Recommended separation distance:
⎡ 3,5
d =⎢
⎢⎣ 3Veff
⎤
⎥ P
⎥⎦
⎡ 3,5 ⎤
d =⎢
⎥ P 80MHz to 800MHz
⎣ 3V / m ⎦
⎡ 7 ⎤
d=⎢
⎥ P 800MHz to 2,5GHz
⎣ 3V m ⎦
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
metres (m).
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site surveya, should
be less than the compliance level in
each frequency rangeb.
Interference may occur in the vicinity
of equipment marked with the
following symbol:
Note1:
Note2:
a.
b.
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 reflection from surfaces, objects, and people.
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and
land mobile radios, amateur 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®.
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®
Technical Specifications
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)
Rated Maximum
Output Power of
Transmitter (W)
150 kHz to 800 MHz
800 MHz to 2,5 GHz
d = 1,2 P
d = 2,3 P
0,01
0,1 m
0,2 m
0,1
0,4 m
0,7 m
1
1,2 m
2,3 m
10
3,8 m
7,3 m
100
12 m
23 m
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in
meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the
maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
Note1:
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.
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:
•
Complete visual inspection
•
Equipment Grounding Conductor Test (DIN EN 60601-1:1990)
•
Leakage Current Measurement Test (DIN EN 60601-1:1990)
•
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
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 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 PhysikalischTechnischen 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.
Technical Specifications
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 I do?
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
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 -> Open.
Q. Can I share with another practitioner just one or a few records,
instead of my entire database?
A. Absolutely. From Patient Management, 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 I 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
Frequently Asked Questions
38
Appendix
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 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.
Glossary
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:
Internet:
info@eidam.com
www.eidam.com
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