Gendex Expert DC Dental X-Ray - User Manual
Gendex Expert DC Dental X-Ray - User Manual
Gendex Expert DC Dental X-Ray - User Manual
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Printed on: 09 Apr 2013, 07:01:56 pm; Printed by: TOBIAS BAUER
Printed on: 09 Apr 2013, 07:01:56 pm; Printed by: TOBIAS BAUER
Table of Contents
Chapter 1 - Introduction
System Components ........................................................................................... 1-1
Articulated Arm ...........................................................................................................1-1
Master Control Touch Panel ........................................................................................1-1
Tubehead ...................................................................................................................1-1
Cone ...........................................................................................................................1-1
Intended Use ...................................................................................................... 1-2
Users .................................................................................................................. 1-2
About This Manual .............................................................................................. 1-2
Service ............................................................................................................... 1-2
Copyright ............................................................................................................ 1-2
Chapter 6 - Maintenance
Equipment Maintenance ..................................................................................... 6-1
Cleaning ............................................................................................................. 6-1
032-0206-EN Rev 8 -v
Printed on: 09 Apr 2013, 07:01:56 pm; Printed by: TOBIAS BAUER
Expert DC User Manual
System Components
The Gendex Expert DC consists of the following components:
Articulated Arm
The tubehead can be positioned with an
extended reach.
Tubehead
• Focal spot indicated by raised
features on cover
• Secondary operator controls
Cone
• Standard 8” (20cm) focal length
• Optional 12” (30cm)
• Optional – Rectangular 8” (20cm) or
12” (30cm)
Intended Use
The Gendex Expert DC is a high frequency X-ray system designed to produce gray scale intraoral
images to film or digital receptors.
Users
This manual is intended for trained dental professionals and authorized Gendex Dealer
Technical Representatives.
Service
Any user maintaining or servicing the Gendex Expert DC unit will void the warranty.
Gendex strongly recommends that only authorized Gendex dealers maintain and service the
Gendex Expert DC.
Copyright
Documentation, Expert DC, and the operating software are copyrighted with all rights reserved.
Under the copyright laws, this documentation may not be copied, photocopied, reproduced,
translated, or reduced to any electronic medium or machine readable form in whole or part,
without the prior written permission of Gendex Dental Systems. Gendex and Gendex Expert DC
are registered trademarks of Gendex.
This manual contains original instructions by Gendex Dental Systems for the safe set-up, use
and maintenance of the Gendex Expert DC.
Safety
This system features continuous operation (stand-by mode). X-rays are emitted only when the
exposure handswitch button is pressed.
With correct handling and installation, proper maintenance and servicing will ensure safe and
efficient operation. The equipment must never be used if there are any electrical, mechanical,
or radiation defects whatsoever.
Refer to the Installation Manual for the recommended maintenance activities (for example,
checking wear and tear on cables, belts, and gears).
Modifications and additions to the equipment must be carried out only by personnel or third
parties that are expressly authorized by, and must comply with the applicable legal
requirements as well as with the generally accepted technical regulations.
Prior to operating the Gendex Expert DC, all laws, regulations, and preventative measures must
be carefully read and addressed for the following conditions:
• Radiation
• Electrical
• Explosion
• Mechanical
Tubehead Leakage
The tubehead contains mineral insulating oil. Such oils are potentially harmful
in case of ingestion or contact with skin or eyes. In case of a defect or fault, an
oil leak can occur. Avoid direct contact with the oil and do not inhale its
vapors. Call your local Service Representative to repair the problem.
In case of minor leaks, the oil can be wiped away with a dry cloth, wearing
protective gloves and flush eyes with copious amounts of water.
In case of minor leakage, the grease can be wiped away with soap and water
and flush eyes with copious amounts of water.
Radiation Safety
X-ray equipment may cause injury if used improperly. The instructions
contained in this manual must be read and followed when installing,
servicing, or operating the Gendex Expert DC. The Expert DC provides a high
degree of protection from unnecessary X-radiation. However, no practical
design can provide complete protection, nor prevent operators from exposing
themselves or others to unnecessary radiation. It is important that you
become fully acquainted with applicable government radiation protection
regulations. Many provisions of these regulations are based on the
recommendations of the National Council on Radiation Protection and
Measurements. Recommendations for dental X-ray protection are published
in NCRP Report Number 35 available from NCRP Publications, 7910
Woodmont Ave., Suite 800, Bethesda, MD 20814, or at www.ncrp.com.
Personal radiation monitoring and protective devices are available. You are
urged to use them to protect against unnecessary X-radiation exposure.
Only qualified and authorized personnel may operate the equipment while
observing all laws and regulations pertaining to radiation protection.
The operator must remain 6 ft. (2m) from the focal spot and the X-ray beam for
operator protection. The operator must use all radiation protection devices,
accessories, and procedures available to protect the patient and operator
from radiation.
NOTE: The Gendex Expert DC Intraoral X-ray unit provides a high degree of
protection from unnecessary radiation. However, no practical design
can provide complete protection nor prevent operators from exposing
themselves or others to unnecessary radiation.
All the safety and operating instructions should be read before the
device is operated. Follow operating and use instructions.
Electrical Safety
Covers on the Gendex Expert DC equipment should only be removed by
qualified and authorized service personnel.
The Gendex Expert DC must be used in areas that comply with all applicable
laws and recommendations pertaining to electrical safety used for medical
purposes (IEC, US National Electrical Code, or VDE standards concerning
provisions of an additional protective earth (ground) terminal for power supply
connection).
Explosion Safety
The Gendex Expert DC must not be used in the presence of flammable or
potentially explosive disinfecting gases or vapors, which could ignite causing
personal injury and/or damage to the equipment. If such disinfectants are
used, the vapor must be allowed to disperse before using the equipment.
Mechanical Safety
If complete safeguarding of the Gendex Expert DC is not possible, extreme
care must be taken to ensure that no body part, especially fingers, or clothing
of the operator or the patient can be trapped or injured by any part of the
equipment. Make sure that fingers are not caught or pinched in the articulated
arm when closing it.
This symbol on the products and/or accompanying documents means that used
electrical and electronic products should not be mixed with general household waste.
For proper treatment, recovery, and recycling, please take these products to designated
collection points where they will be accepted on a free-of-charge basis. Alternatively, in some
countries, you may be able to return your products to your local retailer upon the purchase of
an equivalent new product.
Disposing of this product correctly will help to save valuable resources and prevent any
potential negative effects on human health and the environment which could otherwise arise
from inappropriate waste handling.
Please contact your local authority for further details of your nearest designated collection
point. Penalties may be applicable for incorrect disposal of this waste in accordance with
national legislation.
NOTE: For Business users in the European Union
If you wish to discard electrical and electronic equipment, please
contact your dealer or supplier for further information.
System Labels
The following labels are attached to the system.
Label Description
Medical Equipment REF 110-0205G1
Certification - Complies with FDA radiation
performance standards 21 CFR, Subchapter J.
UL 60601-1, IEC 60601-1, IEC 60601-3,
IEC 60601-2-7, IEC 60601-2-28,
CAN/CSA - C22.2 No. 601.1
Remove this cover to view the primary
identification label.
Class I
Type B
Continuous Operation with Intermittent
Loading
Input Voltage Requirements
Long Term Rating
Max. Momentary Rating
IEC Label
Type B: Protection against electrical shock (IEC 60601-1)
Caution
Consult written instructions in this Manual.
Warning
This X-Ray unit may be dangerous to patient and operator
unless safe exposure factors and operating instructions
are observed.
Warning
Electrical Hazard, Authorized Personnel only.
X-Ray Generator
Recycle Label
Dispose of in accordance with your country’s
requirements. There is material in the system that must
be separately collected and recycled in accordance with
the European Waste Electrical and Electronic Equipment
(WEEE) Directive.
Earth Ground
X-ray Emission
Model Number/Revision
Serial Number
Manufactured Date
Manufactured Location
Tube Head
Continuous; Intermittent
The certified components of the Gendex Expert DC system comply with Radiation Performance
Standards 21 CFR, Subchapter J, at the time of manufacture.
WARNING
The equipment must be installed and operated in accordance with the safety
procedures and operating instructions given in this manual and in the Gendex
Installation Manual for the purposes and applications for which it was
designed.
The Gendex expert DC Master Control Touch Panel contains a microprocessor. The
microprocessor enables and controls exposure values for film and digital imaging receptors.
Preset anatomical time settings allow the user to choose technique values corresponding to
imaging type, anatomical area, or patient type selections.
The values (exposure times with associated intraoral anatomy areas) are preset at the Gendex
factory. The factory default settings are indicated (an LED light appears next to each default
selection) on the master control touch panel when the touch panel is initially turned on for
normal operation.
The default settings or standard factory configuration consists of the following: standard 8”
(20cm) focal length cone, bitewing anatomical section, and film media for an adult patient. For
all other exposure times, the Gendex Factory Default Time Tables are provided in this chapter.
The standard factory configuration presets can be changed from D-speed film to E-speed or F-
speed film, from film to digital, from adult to child, or to a different type of digital imaging
system. The standard cone can also be changed to the optional 12” (30cm) cone.
Cone 8” (20cm) Yes The 8” (20cm) cone is the standard cone for
the Gendex expert DC. The cone can be
changed to an optional 12” (30cm) cone or
to the optional rectangular 8” (20 cm) and
12” (30cm) cones.
The optional, longer 12” (30cm) cone is
used to sharpen the X-ray image if the
paralleling technique is used.
The rectangular cone is used to reduce
the X-ray field size to that of the film. Also,
the rectangular cone helps reduce
radiation to the patient.
Patient Type Adult Yes The default adult type patient can be
changed to the child patient type.
Touch Panel
The master control touch panel consists of the following features and functionality:
Exposure Time Display
Displays the anatomical
exposure time and system
information
Time Selector
Adjust the anatomical
exposure time to a specific
value. The time up arrow and
the time down arrow allows
the user to override the
anatomical exposure time.
Anatomy Selection
(Anatomical Time
Selector)
Select desired tooth area.
When selected, the unit
displays the anatomical
exposure time for the area.
Patient Selector
Toggle to select an adult or a
child patient. Depending on
the selection made, the unit
modifies the anatomical
exposure time.
Imaging Type Selector
Toggle to select between the
use of film or a digital imaging
receptor. The unit modifies
the anatomical exposure time
to suit.
Ready Indicator Lamp
Indicates the On switch was
pushed and the unit is ready
for operation.
Radiation Indicator
Lamp
Warning light illuminates
when exposure button is
pressed and X-ray radiation
is being produced.
Cool Down Indicator
Lamp
Warning light. Illuminates
when the tubehead
becomes heated; indicating
that the tubehead needs to
cool before the next
exposure can be taken.
Push-Button Exposure
Switch
Activates an exposure on
Master Control touch panel.
On/Off Power Switch
Switching ON/OFF power to
the unit. The Ready Indicator
Lamp on the master control
touch panel indicates that
the unit is ready for use.
Coil Exposure Switch
(Not Shown): Exits the
operatory and then activates
an exposure.
Setup
Before operating the Gendex expert DC, you must make the appropriate selections on the
master control touch panel. Refer to the Default Exposure Values (Anatomical Exposure Time)
Tables in this chapter.
NOTE: The default anatomical exposure times, shown in the Default Exposure Values
(Anatomical Exposure Time) Tables, are the factory designated exposure values.
Recommended Occlusal image exposure times are also shown in the tables. While
there is no setting shown on the master control touch panel for Occlusal images,
you can manually set exposure values for Occlusal images by pressing the time up
or time down arrows on the touch panel.
area to toggle to the desired anatomy you wish to X-ray. A green indicator light
appears next to the anatomical section you selected.
Bitewing
Lower Molar
Bicuspid
Incisor
Upper Molar
Operation
CAUTION
If the Cool-Down Indicator Lamp illuminates during normal operation, then the
Gendex expert DC tubehead is heated and needs to cool down before an X-ray
exposure can be taken.
1. Position the tubehead and cone to the patient using standard accepted
positioning procedures.
WARNING
Use extreme care when adjusting the articulated arm to avoid placing your
fingers in areas where they may be potentially pinched while you are moving
the arm. Also, do not allow the tubehead to hit the wall after returning the arm
to the storage position.
CAUTION
In order to comply with regulations and good safety practices, the technique
factors must be visible to the operator.
4. Press and hold the Coil-Cord Switch or Push-Button Exposure Switch until the
audible signal and X-ray exposure indicator light terminates. While the X-ray
Radiation
Indicator
Lamp
Ready
Indicator
Lamp Push-Button
Exposure
Switch
Cool-Down
Indicator
Lamp
NOTE: If you release the Coil-Cord Switch or Push-Button Exposure Switch prior to the
completion of an exposure, the process will immediately terminate with a partial
exposure; the Exposure Time Display will display an error code (Err0). Press any
key, except the Exposure Switch, on the master control panel to clear the error.
5. When the audible signal and X-ray exposure indicator light terminates, return
to the operatory and move the tubehead and cone away from the patient.
6. Follow local practices to view and read film or digital X-ray images.
NOTE: Refer to the Default Exposure Values (Anatomical Exposure Settings) Table in this
chapter.
When a different film or digital speed is selected, the unit automatically uses
exposure times associated with the new selection.
Prerequisite
Before changing film or digital speed, make sure the unit is turned off.
Change to E-Speed
1. Press and hold the Anatomical Time Selector then turn the On/Off power
switch to the On position. The film or digital icon will be flashing and the
LED will display SP1, SP2, SP3, D1, or D2. An SP or D setting confirms that
the unit is in the media type programming menu.
a. If the film icon indicator is flashing, no selection is required.
b. To change to a different media type, press the Imaging Type Selector
to toggle to the film icon.
NOTE: When changing the media type, you must quickly press the Imaging Type Selector.
If there is no keypad activity for 30 seconds, the unit will not remain in the
programming mode, changes will not be saved, and the unit will return to normal
operation
2. Press the time up or time down arrows until the LED displays SP2. The SP2
setting confirms that the unit is now set for E-speed film.
3. Press the Anatomical Time Selector again to store the new setting. The
new time, 0.200 seconds, will be displayed for the bitewing, (the default
anatomical selection).
Change to F-Speed:
1. Press and hold the Anatomical Time Selector then turn the On/Off power
switch to the On position. The film or digital icon will be flashing. An SP or
D setting confirms that the unit is in the media output programming
menu.
a. If the film icon indicator is flashing, no selection is required.
b. To change to a different media type, press the Imaging Type Selector
to toggle to the film icon.
Time Selectors
Anatomical Time
Selector
Imaging Type
Selector
2. Press the time up or time down arrows until the LED displays SP3. The SP3
setting confirms that the system is now set for F-speed film.
3. Press the Anatomical Time Selector again to store the new setting. The
new time, 0.125 seconds, will be displayed for the bitewing, (the default
anatomical selection).
Change to Digital D1
NOTE: When the digital icon is selected, the system automatically uses
exposure times associated with digital D1 or D2.
1. Press and hold the Anatomical Time Selector then turn the On/Off power
switch to the On position. The film or digital icon will be flashing. An SP or
D setting confirms that the system is in the media output programming
menu.
a. If the digital icon indicator is flashing, no selection is required.
b. To change to a different media type, press the Imaging Type Selector
to toggle to the digital icon.
2. Press the time up or time down arrows until the LED displays D1. The D1
setting confirms that the system is now set for digital imaging.
3. Press the anatomical time selector again to store the new setting. The
new time, 0.160 seconds, will be displayed for the bitewing, (the default
anatomical selection).
Change to Digital D2
1. Press and hold the Anatomical Time Selector then turn the On/Off power
switch to the On position. The film or digital icon will be flashing. An SP or
D setting confirms that the system is in the media type programming
menu.
a. If the digital icon indicator is flashing, no selection is required.
b. To change to a different media, press the Imaging Type Selector to
toggle to the digital icon.
2. Press the time up or time down arrows until the LED displays D2. The D2
setting confirms that the system is now set for a CCD or CMOS type digital
imaging receptor.
3. Press the anatomical time selector again to store the new setting. The
new time, 0.080 seconds, will be displayed for the default bitewing, (the
default anatomical selection).
Occlusal exposure values are also shown in separate tables. While there is no setting shown on
the master control touch panel for Occlusal exposures, you can manually set the exposure
values for Occlusal exposures by pressing the time up or time down arrows on the touch panel.
Lower Molar 0.320 second 0.160 second 0.630 second 0.320 second
Upper Molar 0.400 second 0.200 second 0.800 second 0.400 second
Lower Molar 0.200 second 0.100 second 0.400 second 0.200 second
Upper Molar 0.250 second 0.125 second 0.500 second 0.250 second
Lower Molar 0.125 second 0.063 second 0.250 second 0.125 second
Upper Molar 0.160 second 0.080 second 0.320 second 0.160 second
Lower Molar 0.160 second 0.080 second 0.320 second 0.160 second
Upper Molar 0.200 second 0.100 second 0.400 second 0.200 second
Lower Molar 0.080 second 0.040 second 0.160 second 0.080 second
Upper Molar 0.100 second 0.050 second 0.200 second 0.100 second
D1: PSP 0.250 second 0.125 second 0.500 second 0.250 second
Plate
Receptors
CAUTION
If the Cool-Down Indicator Lamp illuminates during normal operation, then the
Gendex Expert DC tubehead is heated and needs to cool down before an X-ray
exposure can be taken.
1. Position the tubehead and cone to the patient using standard accepted
positioning procedures.
WARNING
Use extreme care when adjusting the articulated arm to avoid placing your
fingers in areas where they may be potentially pinched while you are moving
the arm. Also, do not allow the tubehead to hit the wall after returning the arm
to the storage position.
CAUTION
In order to comply with regulations and good safety practices, the technique
factors must be visible to the operator.
4. Press and hold the Coil-Cord Switch or Push-Button Exposure Switch until the
audible signal and X-ray exposure indicator light terminates. While the X-ray
Radiation
Indicator
Lamp
Ready
Indicator
Lamp Push-Button
Exposure
Switch
Cool-Down
Indicator
Lamp
NOTE: If you release the Coil-Cord Switch or Push-Button Exposure Switch prior to the
completion of an exposure, the process will immediately terminate with a partial
exposure; the Exposure Time Display will display an error code (Err0). Press any
key, except the Exposure Switch, on the master control panel to clear the error.
5. When the audible signal and X-ray exposure indicator light terminates, return
to the operatory and move the tubehead and cone away from the patient.
6. Follow local practices to view and read film or digital X-ray images.
The Gendex Expert DC Master Control Touch Panel provides the user with the capability to
expand film and digital options. The user can set and maintain custom anatomical presets for
film and for digital imaging.
Prerequisite
Before you change film or digital speed, make sure the unit is turned off.
1. Press and hold the Anatomical Time Selector and the Imaging Type
Selector then turn the On/Off power switch to the On position.
Time Selectors
Anatomical Time
Selector
Patient Selector
Imaging Type
Selector
2. Release the Anatomical Time Selector and the Imaging Type Selector
switches. The LED display will show the current exposure time and you
will see the flashing lamps next to the Anatomical Time Selector, Imaging
Type Selector, and the Patient Selector. The flashing lights indicate that
the unit is in the customized programming mode.
3. The film or digital icon will be flashing.
a. If the correct film or digital icon is illuminated or flashing, no selection
is required.
b. To change to a different media, press the Imaging Type Selector to
toggle to the film or digital icon.
NOTE: If there is no keypad activity for 30 seconds, the unit will not remain in
the programming mode, changes will not be saved, and the unit will
return to normal operation.
4. Select the anatomical type and the patient type you wish to set.
5. Using the time up or time down arrows, set the exposure value until the
desired value is displayed for the anatomical setting, the patient type, and
the imaging type you selected.
6. To set additional custom values for anatomical, patient, and imaging
values, repeat steps 1 – 5.
7. To exit the programming mode, press the Anatomical Time Selector and
then the Imaging Type Selector together to exit and return the unit to
operation.
NOTE: The imaging type startup default will be the last selected media output
when the programming mode was exited. The patient type default will
be the last selected patient type.
*Note: Settings are only applicable until they are changed by user selected values from 0.02s
to 2.00s
Error conditions
The Gendex Expert DC Master Control Touch Panel provides the user with the capability to
manage some error conditions.
The green Ready lamp, amber Cool-down lamp and digital Exposure Time Display on the front
of Gendex Expert DC Master Control Touch Panel can provide indications that errors have
occurred. The following chart provides an explanation of what the indicators mean and the
action that is needed to address the condition.
The amber Cool-down Normal operation by Wait until lamp goes out;
Indicator Lamp comes on design. Cool-down lamp indicates that the tube
and exposure cannot be comes on if too many has properly cooled
made exposures are made in a down.
short period of time. This
feature protects and
extends the life of the
tubehead.
Err0 flashes on the The exposure has been Pressing any key except
Exposure Time Display terminated prematurely. the exposure switch on
This can be caused by the master control touch
an equipment malfunc- panel will clear the dis-
tion or the operator play and restore normal
releasing the exposure operation. Care must be
switch prior to the end of taken to press and hold
the exposure time the exposure button until
selected. the exposure is finished.
Err1 flashes on the Power Supply voltage Wait until line voltage
Exposure Time Display was outside of required returns to normal (indi-
range: cated by the return to
108V – 132V normal display rather
198V – 253V than error indication) or
have a qualified electri-
cian check the power
line.
Err2 is displayed on the Power Supply voltage Pressing any key on the
Exposure Time Display dropped below the mini- master control touch
mum requirement (108V panel will clear the flash-
or 198V) during the expo- ing and restore normal
sure. The exposure is not operation. If the problem
terminated but X-ray out- persists, it is strongly rec-
put may be low. ommended that a quali-
fied electrician check the
power line.
Err3 flashes on the A hardware fault has Reset the unit by turning
Exposure Time Display occurred. Off the power switch for
30 seconds and then
turning On the power
switch. If the problem
persists, contact your
authorized Gendex
Dealer Technical Repre-
sentative.
Err4 flashes on the A fault has occurred and Pressing any key except
Exposure Time Display terminated the exposure. the exposure switch on
the master control touch
panel may clear the Error
and restore normal oper-
ation. If the problem per-
sists, contact your
authorized Gendex
Dealer Technical Repre-
sentative.
To ensure a safe and functional Gendex Expert DC product, a maintenance program must be
established. It is the owner’s responsibility to arrange for maintenance service and to ensure
that the personnel performing the maintenance are fully qualified to service Gendex Expert DC
equipment.
Equipment Maintenance
Calibration and function checks must be performed on the Gendex Expert DC at installation and
on a yearly basis. The calibration and function checks are listed in the System and Function
Checks section of the Gendex Expert DC Installation manual supplied with the product.
Gendex recommends that cleaning and general maintenance be performed on the Gendex
Expert DC on a routine basis.
WARNING
To avoid any potential hazard or danger to operators and patients, contact
your authorized Gendex Technical Representative immediately if you
experience any unusual operation, mechanical issues, or equipment
malfunction.
Cleaning
WARNING
To protect against electrical shock, before cleaning, electrically disconnect the
equipment from the mains electrical supply.
Cooling and duty rating specification apply at altitudes up to 12,000 ft. (3,600 m), average
relative humidity not exceeding 90 percent, and maximum ambient temperature not exceeding
104 degrees F (40 degrees C).
Tubehead Specifications
The tubehead specifications consist of the following:
Leakage radiation in the loading state: Less than 250 micro Gy/h at 1 meter from
the focal spot.
Cone Specifications
The cone specifications consist of the following:
1. X-ray Field Size: Containable in a 6 cm diameter circle, measured at the
distal end of the installed cone.
2. Distance from the focal spot to the distal end of the cone is: 8” or 12“ (20
or 30 cm).
NOTE: If the line voltage falls outside the range, proper operation may be jeopardized.
Contact an electrical contractor in your area.
Tube Potential 65 kV ± 3 kV
Current 7mA ± 5%
Physical Specifications
Shockproof Housing: Zinc, hermetically sealed under vacuum with high
dielectric insulating oil. Inherent to the housing is an
expansion chamber designed to provide adequate
compensation for the full temperature range.
Operating Temperature: +50°F to 100°F (+10°C to +40°C)
Storage Temperature: -40°F to 160°F (-40°C to +70°C)
Inherent Filtration:
Thermal Characteristics:
• Housing Heat Storage Capacity 250 kHU’s (177J)(see graph for more detail)
• Maximum Cooling Rate 3.3 kHU’s/Min.
Guidance and Manufacturer’s Declaration - electromagnetic emissions -for all equipment and
systems (see 6.8.3.201 a) (3).
The Gendex Expert DC is intended for use in the electromagnetic environment. The customer or
the user of the Gendex Expert DC must ensure that it is used in such an environment.
Electromagnetic Environment -
Emissions Test Compliance
Guidance
Guidance and Manufacturer’s Declaration - electromagnetic immunity -for all equipment and
systems (see 6.8.3.201 a) 6)).
The Gendex Expert DC is intended for use in the electromagnetic environment specified below.
The customer or user must ensure that it is used in such an environment.
Electrical fast +/-2 kV for power +/-2 kV for power Mains power quality should
transient/burst supply lines supply lines be that of a typical commer-
cial or hospital environ-
IEC 61000-4-4 +/-1 kV for input/output +/-1 kV for input/output ment.
lines lines
<5 % UT <5 % UT
(>95 % dip in UT) (>95 % dip in UT)
for 5 sec for 5 sec
Note: UT is the a.c. mains voltage prior to application of the test level.
Guidance and Manufacturer’s Declaration - electromagnetic immunity -for all equipment and
systems that are not life-supporting (see 6.8.3.201 b).
The Gendex Expert DC is intended for use in the electromagnetic environment specified below.
The customer or user must ensure that it is used in such an environment.
Guidance and Manufacturer’s Declaration –Electromagnetic Emissions
IEC 60601 Compliance
Immunity Test Electromagnetic Environment – Guidance
Test Level Level
Portable and mobile RF communications equipment
should be used no closer to any part of the Gendex
Expert DC, including cables, than the recommended
separation distance calculated from the equation
applicable to the frequency of the transmitter.
Recommended separation distance
Conducted RF 3 Vrms 3V
Note 1 At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
• Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which
the Gendex Expert DC is used exceeds the applicable RF compliance level above, the Gendex Expert DC
should be observed to verify normal operation. If abnormal performance is observed, additional measures
may be necessary, such as re-orienting or relocating the Gendex Expert DC.
• Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1] V/m
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in metres (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to
the transmitter manufacturer.
Note 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
Note 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
Equipment Standards
The System was tested and/or evaluated against and found compliant to the following
standards/requirements:
Signature Manifest
Document Number: 032-0206-EN Revision: 8
Title: eXpert DC, User Manual, English
All dates and times are in Eastern Standard Time .
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Printed on: 09 Apr 2013, 07:01:56 pm; Printed by: TOBIAS BAUER
5/21/2012