Professional Documents
Culture Documents
Operator Manual
Manufactured by
DO NOT OPERATE THIS DEVICE UNTIL YOU HAVE READ THIS MANUAL and reviewed the
accompanying materials.
Disclaimer: The NOMAD MD is sold with the understanding that the user assumes sole
responsibility for radiation safety (as well as any state, provincial, or local regulatory compliance)
and that Aribex and its agents or representatives do not accept responsibility for the following:
a) injury or danger to personnel from X-ray exposure,
b) image over/under exposure due to poor operating techniques or procedures,
c) equipment not properly serviced or maintained in accordance with instructions
contained in this publication, and
d) equipment which has been damaged, modified, or tampered with in any way.
Aribex and NOMAD are registered trademarks within the United States and other countries.
NOMAD MD, NOMAD 75kV, NOMAD Dental, NOMAD Pro, NOMAD Pro 2, PORTA-X, and
the ARIBEX and NOMAD logos are trademarks of Aribex worldwide. Product protected in other
countries by one or more issued patents. U.S. patents issued: 7,224,769 and 7,496,178. Other
United States and international patents pending. All other brand and product names are trademarks
or registered trademarks of their respective companies.
Ionizing Radiation
At Aribex we value your business and we would like to hear from you because your
feedback and suggestions are important to us. If you have comments, please contact
us by emailing support@aribex.com or calling 1-866-340-5522.
• Exposure Safety Feature – Cannot emit X-rays with insufficient voltage (low battery).
• Engineered for Compatibility – Works with film, phosphor plate (CR), and digital (DR)
radiography systems.
• Security Lock-out Feature – Enables the safe training, demonstration, and storage
of the device without undue concern related to unintended or unauthorized radiation
emission.
• Authorized Service – Complete support and maintenance from Aribex and through
our authorized distributors.
1.0 Getting Started
1.1 Intended Use/Indications for Use
The NOMAD MD is a handheld and portable general purpose X-ray system. The device
uses a fixed tube current and voltage (kVp) and, therefore, is limited to taking diagnostic
X-rays of extremities.
It is intended to be used by a qualified and trained clinician on both adult and pediatric
patients. It is not intended to replace a radiographic system with variable tube current and
voltage (kVp) which may be required for full optimization of image quality and radiation
exposure for different exam types.
Caution: U.S. Federal law restricts this device to sale by or on the order of a
physician or other licensed practitioner.
• NOMAD MD Device with SSD (Source to Skin Distance) cage and integrated
inclinometer attached
• Battery Charger (the charger should be appropriate for local AC line voltage; actual
color/style/model may differ)
Certificate of Conformance
6
Preliminary Checks:
Item Check
Device Labels Verify that the device labels (the serial number label located on the
backside of the shutter ring housing and the warning label across the foot
of the device) are legible and in place.
Other Labels Verify that the serial number on the warranty/registration card (see
number 3 below) matches the device serial number and the device
carrying case serial number.
Collimator Cone Inspect for shipping damage.
Control Panel Check that panel face is smooth and free of nicks, scratches, or other
damage.
Trigger Switch Check that trigger moves freely in and out when depressed and
released.
Device Housing Check that housing is free of cracks or fractures.
SSD Cage Check that cage is firmly attached to the collimator cone and that it is not
cracked or broken.
Shutter Rings Verify the following: the ring with the larger tabs furthest from the operator
moves the outer shutters to adjust the horizontal size; the ring with the
smaller tabs closest to the operator moves the inner shutters to adjust
the vertical size. Rotating tabs clockwise closes the shutters; rotating tabs
counterclockwise opens the shutters.
Inclinometer Check that face and casing are smooth and free of nicks, scratches, or
other damage. Needle inside of inclinometer should respond to tilting of
the device.
Complete the product warranty/registration card and mail it with proper postage to
Aribex today. This can also be completed on the NOMAD MD website: NOMADMDXray.com/
warranty-registration/. Completing the card fulfills a condition of warranty coverage (see
Section 8.5 Limited Warranty) and enables you to receive valuable product news and
updates.
Fully charge the battery before placing it into long-term storage (over 30 days). After
placing the battery into long-term storage, it is recommended that the battery be fully
recharged every 3 months.
Unwrap the power cord of the battery charger and connect it to an AC electrical
outlet (110/120V or 220/240V, dictated by the country/region).
7
Position the battery charger away from the
normal patient environment. A plug adapter
may be used as needed; use only the
supplied battery charger (for manufacturer
and model info, see Section 7.0 Maintenance
and Repair.
When the battery is fully charged and ready to use, the indicator light will stop
flashing and remain on continuously. Remove the charged battery and charge the
second battery for future use.
After the initial 30 to 45 minute recharge, the charger will switch to Tune-Up
Mode, which continues for 8 hours while cells in the battery are equalized. The
battery is ready for use and can be removed at any time during Tune-Up Mode.
Always unplug the charger from the power supply when it is not in service. For
additional info specifically about the charger, see the accompanying instruction
manual for the battery charger. Also see Section 5.0 Battery Replacement and Care.
8
2.0 Safety Precautions
2.1 Radiation Safety
The NOMAD MD was designed to be used in both clinical settings (e.g., a radiology
department) and controlled settings where transportation or use of other X-ray devices
might be prohibitive due to the device’s size and/or mobility.
This X-ray unit may be dangerous to patient and operator unless safe exposure factors
and operating instructions are observed. Safety equipment used with this device should
be fully tested and certified, and CE marked for compliance with the EU PPE (personal
protective equipment) Directive.
This X-ray unit must only be operated by trained personnel in a controlled setting.
Within such a setting, ensure that only the patient is in the direct beam of the x-ray, and
that any ancillary personnel are a minimum of 3 meters (approximately 9 feet) away
from the patient. If it is necessary for any ancillary personnel to be closer than 3 meters,
these personnel should stay out of the direct beam and wear personal protective
equipment (PPE), such as an apron (with 0.5mm lead equivalent) and thyroid collar.
However, any structural enclosures (e.g., barriers or walls) in the controlled setting will
reduce the zone requiring PPE use (see figure below). Safety equipment used with this
device should be fully tested and certified, and CE marked for compliance with the EU
PPE Directive.
• The NOMAD MD
provides a high degree
of protection from
unnecessary radiation.
However, no practical
design can provide
complete protection nor
Measureable
prevent operators from
Scatter Radiation
exposing themselves or
others to unnecessary
radiation. It is important Operator 1.4 meters
Zone
to restrict use and Patient
follow all applicable
government radiation
protection regulations. 3 meters
Pregnant women should
not be exposed to X-rays
unless necessary. Proper
safety precautions should Encroachment Zone with PPE Use
be taken to minimize
dose to the fetus.
9
instructions provided by Aribex, no additional
skills, training, or knowledge are required.
Operators should always wear PPE while using the NOMAD MD in order to be shielded
from backscatter radiation. Both an apron (with 0.5mm lead equivalent) and thyroid
collar are recommended. For those operators who take over 5000 exposures a year,
radiation protective eyewear is also recommended. Safety equipment used with this
device should be fully tested and certified, and CE marked for compliance with the EU
PPE Directive.
The SSD cage is designed to maintain a minimum source to skin distance per FDA
requirements. Do NOT remove the SSD cage from the NOMAD MD in order to bring the
X-ray source closer to the patient. Do NOT make any other modifications to the device.
Doing so highly increases radiation exposure risks for the patient and will void the
NOMAD MD warranty. In addition, do NOT stick extremities (hands, feet, fingers, toes)
inside of the SSD cage in order to bring the X-ray source closer to the patient, since this
also increases radiation exposure risks for the patient.
10
2.2 Studies and Data on Leakage and Scatter
Besides direct beam, potential exposure from X-ray devices has only two other possibilities:
Leakage
The primary protective shielding of the NOMAD MD blocks leakage radiation, allowing
safe handheld use of the NOMAD MD. Aribex has set and continually meets an internal
standard for leakage well below regulations.1
Scatter
In order to fully assess backscatter to the operator, Aribex has conducted an internal study
to measure these levels.2 After positioning the NOMAD MD 28 inches (the recommended
operating distance) from a secured phantom, a total of 672 X-ray exposures were fired
remotely. A radiation-detecting ion-chamber was rotated to various positions in the room
for each exposure. The resulting data were graphed to delineate the Significant Zone of
Occupancy (or Operator Zone) for both the vertical (Chart 1) and horizontal (Chart 2)
axes:
1 IEC 60601-1-3, Part 29.203.4 gives a leakage radiation limit of 250 µGy/hr (0.250 mGy/hr), at 1 m from the device enclosure, while
Aribex follows a standard of 20 µGy/hr (0.020 mGy/hr), at 5 cm from the device enclosure.
2 TP-0223, Test Case, Scatter Radiation, NOMAD MD (75kV)
11
90
80
60
50
140
40
130
120
30
110
20
100
Horizontal 1090
Significant Zone of
080
Occupancy: 70
60 cm x 60 cm 60
50
40
30
20
10
0.0 - 10 μGy/hr
11 - 20 μGy/hr
21 - 40 μGy/hr
> 81 μGy/hr
12
90
80
Chart 2: Horizontal Axis, 60 cm X 70
60 cm
60
50
140
40
130
120
30
110
20
100
Horizontal 10
90
Significant Zone of
0
80
Occupancy: 70
60 cm x 60 cm 60
50
40
30
20
10
0.0 - 10 μGy/hr
11 - 20 μGy/hr
21 - 40 μGy/hr
41 - 80 μGy/hr
> 81 μGy/hr
IEC 60601-1-3, Part 29.208-4 gives a backscatter radiation limit of 20 µGy/hr with a
Significant Zone of Occupancy measuring 200 cm high, 60 cm wide, and 60 cm deep:
otherwise, PPE is required. As is demonstrated by Charts 1 and 2, the Significant Zone of
Occupancy for the NOMAD MD contains radiation measurements from the 0 to 40 µGy/hr
range:
Operators should always wear PPE while using the NOMAD MD in order to be shielded
from backscatter radiation. Both an apron (with 0.5mm lead equivalent) and thyroid
collar are recommended. For those operators who take over 5000 exposures a year,
radiation protective eyewear is also recommended. Safety equipment used with this
device should be fully tested and certified, and CE marked for compliance with the EU
PPE Directive.
13
2.3 Usage and Duty Cycle
An exposure can be terminated for any reason by abruptly releasing the depressed trigger
(for more information, see Section 4.0 Operation).
As a safety feature, the NOMAD MD will not emit X-rays with insufficient voltage (low
battery).
The NOMAD MD is also designed to avoid damage from overheating. The minimum
duty cycle rating for maximum exposure (the relationship between duration and frequency
of exposures taken during a rolling 60 second period) is 1:60. The following table shows
examples of optimal use:
Do not operate the NOMAD MD or the battery charger if either was immersed in
liquid or subjected to an undue amount of moisture. Return to Aribex for an evaluation.
• Do not open the housings. Doing so will void the warranty. There are no user
serviceable parts inside the NOMAD MD.
• The NOMAD MD should not be used in environments where flammable cleaning
agents are present.
• Locate the battery charger away from the normal patient environment.
2.4 Cleaning
Turn off the power and detach the battery before cleaning. Ensure the battery charger
is unplugged before attempting to clean it.
Use a non-acetone based disinfectant wipe (with less than 17% alcohol content) or
a cloth to wipe the exterior surfaces of the NOMAD MD and charger. Do not use cleaners
intended for hard metal surfaces, since certain chemical combinations may deteriorate the
NOMAD MD plastic prematurely.
NOTE: The NOMAD MD and the accompanying battery charger are not designed to be
subjected to any kind of heat sterilization procedure.
14
• Aribex recommends that the NOMAD MD (like
all electronic equipment) be allowed to acclimate
before use when switching between temperature
extremes (i.e., cold storage area to a hot use area
or hot storage area to a cold use area).
15
• The NOMAD MD should not be operated if it has been dropped, if performance
degrades, if the SSD cage has been broken or compromised in any way, or if the
light field fails to function; it should be returned to Aribex for an evaluation.
• Fully charge the battery before placing it into long-term storage (over 30 days).
After placing the battery into long-term storage, it is recommended that the battery
be fully recharged every 3 months.
Make sure the battery is secure by giving it a tug. The NOMAD MD can be placed
into service after the operator has checked for power (see Section 3.2 Checking for Power
and Adequate Charge).
Read the battery charger instruction manual for complete information on how to
achieve the longest life and best performance from your batteries.
If the battery is too low, the red Low Battery indicator at the lower right of the
control panel will flash, accompanied by an intermittent audible signal .
Once a battery is depleted, indicated by the Low Battery alert, it must be recharged
before use.
16
For continued use, insert the secondary, replacement battery (which should be
charged in advance).
This X-ray unit may be dangerous to testing technician and any bystanders unless safe
test exposure factors, such as placing the test detector in a lead lined box or the use
of an apron (with 0.5mm lead equivalent) and thyroid collar, are observed. Safety
equipment used with this device should be fully tested and certified, and CE marked for
compliance with the EU PPE Directive.
• On/Off Switch: To verify the On and Off conditions, install a fully charged battery to
the NOMAD MD device. Press the Power button. The device should turn on. To turn
off the device, press the Power button.
• Exposure Time Buttons (Up and Down Arrows): With the device turned On and
the security lock disengaged, press each of the increase buttons then each of the
decrease buttons and verify that the exposure times shown on the LED display change
appropriately. Pressing the hundredths up button will cause the display to go from “00”
to “02.” Pressing the hundredths down button will cause the display to go from “02” to
“00.” This is because the value “01” is not a viable exposure time. The exposure time
buttons have a scrolling feature—press down and hold on either the up or down arrow
in order to scroll through the different time settings.
• Enable Switch: With the device turned On and the LED exposure display set at 50
(500ms), press the Enable button and verify functional conditions. Wait approximately
20 seconds, at which point the enabled condition should expire.
• Automatic Shutdown: Press the Power button to turn the device On and wait for
it to automatically shut off after approximately 2.5 minutes of inactivity.
17
4.0 Operation
4.1 Powering Up
NOTE: Manufacturer’s recommendation is for
the operator to wear nitrile or other gloves First press here
during basic operation of the NOMAD MD.
The NOMAD MD is designed and tested to be Second press here
capable of operating inside a transparent and
protective bag.
Decrease
SCHEDULES ARE OBSERVED.
button. buttons
18
4.3 Preparing to Enable the Device
The NOMAD MD has several unique Adjusts Horizontal Size
features that you should familiarize yourself
with before attempting to enable the device
Adjusts Vertical Size
and perform exposures.
19
4.4 Situating the Patient and Enabling the Device
To prevent accidental exposure, properly Press to enable
position the patient and yourself before
enabling the NOMAD MD.
For other error conditions, see Section 6.1 Alarms and Alerts or Section 6.2
Troubleshooting.
NOTE: An exposure can be prematurely terminated for any reason by abruptly releasing
the depressed trigger. The X-rays On and Start buttons will repeatedly flash
simultaneously, accompanied by an audible signal . This condition will continue for 10
seconds, after which the device may be re-enabled.
20
When the laser is aligned with the center of the
reticle, the NOMAD MD X-ray source is 28 inches
(71.12 cm) from the patient. (The center of the 101 cm 40”
reticle also marks the center of the light field.) For 91 cm 36”
each tick mark above the middle of the reticle that 81 cm 32”
71 cm 28”
the laser travels up, the X-ray source becomes 4 61 cm 24”
inches (10.16 cm) further from the patient. For
each tick mark below the reticle that the laser 51 cm 20”
travels down, the X-ray source becomes 4 inches
(10.16 cm) closer to the patient.
The laser used in the NOMAD MD is a Class 2 laser. Operators should take extra
precautions to not shine the laser in their own eyes, the eyes of the patient, or anyone
else’s eyes.
The SSD cage is designed to maintain a minimum source to skin distance per FDA
requirements. Do NOT remove the SSD cage from the NOMAD MD in order to bring the
X-ray source closer to the patient. Do NOT make any other modifications to the device.
Doing so highly increases radiation exposure risks for the patient and will void the
NOMAD MD warranty. In addition, do NOT stick extremities (hands, feet, fingers, toes)
inside of the SSD cage in order to bring the X-ray source closer to the patient, since this
also increases radiation exposure risks for the patient.
21
4.5 Initiating and Completing an X-ray Exposure
After enabling the NOMAD MD, make final Press and hold to initiate X-ray
adjustments for shutter dimensions and distance
from the patient. Line up the red laser dot with
the middle point of the reticle, or at another
point on the reticle, depending on the desired
exposure.
To ensure complete exposure, keep the trigger THIS X-RAY UNIT MAY BE DANGEROUS TO PATIENT
AND OPERATOR UNLESS SAFE EXPOSURE FACTORS,
OPERATING INSTRUCTIONS AND MAINTENANCE
To minimize cone-cutting,
the NOMAD MD must be properly
positioned relative to the imaging system. The light field
and laser should be used to assist in properly aligning the
NOMAD MD and detector.
22
Determine which time settings, angles, shutter widths, and distances deliver optimal
results for the type of digital or film-based imaging that is done on a regular basis. Note
that digital imaging sensors and film speeds can vary somewhat in their characteristics
and could require different exposure settings than the suggested nominal exposure times
shown in Section 4.8 Adult Technique Chart and Section 4.11 Pediatric Technique Chart.
Adjust as needed to meet density preference. The body part being imaged should be
unobstructed during the exposure.
For an explanation of the relationship between shot duration and rest cycle between
exposures (also known as the duty cycle), see Section 2.3 Usage and Duty Cycle.
Operators should always wear PPE while using the NOMAD MD in order to be shielded
from backscatter radiation. Both an apron (with 0.5mm lead equivalent) and thyroid
collar are recommended. For those operators who take over 5000 exposures a year,
radiation protective eyewear is also recommended. Safety equipment used with this
device should be fully tested and certified, and CE marked for compliance with the EU
PPE Directive.
Do NOT remove the SSD cage from the NOMAD MD in order to bring the X-ray source
closer to the patient. Do NOT make any other modifications to the device. Doing so
highly increases radiation exposure risks for the patient and will void the NOMAD MD
warranty. In addition, do NOT stick extremities (hands, feet, fingers, toes) inside of the
SSD cage in order to bring the X-ray source closer to the patient, since this also increases
radiation exposure risks for the patient.
23
4.8 Adult Technique Chart
The NOMAD MD has been validated to capture diagnostic quality images of body
part extremities. For the scope of this device, an extremity is defined as any body part
projecting from the torso other than the head. This includes body parts such as fingers
(from 1.5cm) and thighs (up to 21cm). The following theoretical dosage technique chart
was developed to assist clinicians in providing the lowest exposure time to non-pediatric
patients of all sizes. A technique chart specific to pediatric patients is provided in Section
4.11 Pediatric Technique Chart.
Elbow 0.04 0.08 0.12 0.16 0.20 0.24 0.42 0.48 0.54 0.60 0.66 0.72 0.78 0.84
AP Hand 0.03 0.06 0.09 0.12 0.15 0.18 0.32 0.36 0.41 0.45 0.50 0.54 0.59 0.63
Lat Hand 0.05 0.09 0.15 0.20 0.25 0.30 0.35 0.40 0.58 0.65 0.71 0.77 0.84 0.90
Femur 0.07 0.14 0.21 0.28 0.35 0.42 0.50 0.56 0.63 0.71 0.76 0.85 0.92 0.99
Knee 0.07 0.14 0.21 0.28 0.35 0.42 0.50 0.56 0.63 0.71 0.76 0.85 0.92 0.99
Ankle 0.04 0.08 0.12 0.16 0.20 0.24 0.42 0.48 0.54 0.60 0.66 0.72 0.78 0.84
AP Foot 0.04 0.08 0.12 0.16 0.20 0.24 0.42 0.48 0.54 0.60 0.66 0.72 0.78 0.84
Lat Foot 0.05 0.09 0.15 0.20 0.25 0.30 0.35 0.40 0.58 0.65 0.71 0.77 0.84 0.90
24
4.9 Adult Dose Value Chart
Typically, dose value is proportional to the quality of the images obtained. Appropriate
considerations should be made for adult patients to assure appropriate dose is maintained
based on mAs settings.
25
4.11 Pediatric Technique Chart
Use of equipment and exposure settings designed for an average-sized adult can result in
excessive radiation exposure for a smaller patient, especially a pediatric patient. Studies3
have shown that pediatric patients may be more radio-sensitive than adults (i.e., the
cancer risk per unit dose of ionizing radiation is higher), and so unnecessary radiation
exposure is of particular concern for pediatric patients. The NOMAD MD will work with
current pediatric positioning devices. Normal immobilization is recommended for quality
imaging of pediatric patients. Please use caution when configuring the NOMAD MD by
considering the patient’s age, size, body habitus, and clinical indication when verifying
exposure time settings.
For pediatric patients, which include neonates, infants, children, and adolescents, special
effort should be made to reduce radiation dose, when diagnostically feasible. Please
consider the following when preparing to image a pediatric patient:
• Position the patient properly. Due to the flexible nature of the NOMAD MD, retakes
can be reduced by moving the device instead of the patient to achieve the required
image. This is especially important when the patient may be physically compromised
due to injury.
• Collimate prior to exposure. The NOMAD MD has the ability to collimate down to 1.3
cm by 1.3 cm. X-ray only the indicated area with proper collimation. This will reduce
the overall radiation dose as well as prevent excess scatter from degrading image
contrast and resolution.
• Shield gonads/breasts/thyroid and other body parts not being imaged when possible.
• Make your decisions so that retakes of X-rays are kept to a minimum or are not necessary.
Because pediatric patients are generally anxious during any medical procedure, the
following guidelines should be followed to ensure the patient is calm and still during an
X-ray procedure. Following these important guidelines will also help to avoid retakes.
• Stay with the patient at all times in order to ensure that the patient remains still
during the X-ray procedure. The NOMAD MD is sufficiently shielded internally and
has a very low dose output, which allows for the X-ray technologist to remain with the
patient during exposures. The technologist should be properly trained and should use
protective equipment as recommended. Do not attempt to acquire the image until the
patient is sufficiently calm and immobile.
• Ask a parent or other responsible adult to remain in the examination room during the
exposure. Because of the low dose output of the NOMAD MD, adults can safely remain
in the same room with the patient during the examination. Show the parent where to
3 NAS National Research Council Committee to Assess Health Risks from Exposure to Low Levels of Ionizing Radiation. 2006. Health
risks from exposure to low levels of ionizing radiation: BEIR VII phase 2. Washington, D.C.: National Academy of Sciences, National
Academies Press.
26
stand in the exam room during the exposure. Remember, any ancillary personnel must
be at least 9 feet (3 meters) away from the patient during exposures, or wear PPE.
Since exposures involve the use of radiation, ask women whether they are pregnant or
believe they may be pregnant before proceeding with any exposures. If the answer is
yes, request that another adult accompany the child during the exposure.
• Instruct adults who remain in the examination room to refrain from distracting the
medical team or interrupting the exposure in any way. The most important role of an
adult during the exposure is to help the patient stay calm and relaxed.
• Acquire all X-ray exposures in a timely manner. Since the only adjustments needed
on the NOMAD MD are collimation and time setting, the device allows for quick
acquisition of images. Be sure to collimate before exposure to reduce or eliminate the
possibility of retakes.
Proper use of the following pediatric technique chart, based on thickness for child sizes,
will help to ensure a quality image, reduce overall dose to the patient, and reduce the
potential of retakes. Following ALARA (As Low As Reasonably Achievable) principles, the
pediatric time settings have been reduced 40% from adult settings. This reduction is based
on a study conducted by the American College of Radiology.4
Elbow 0.02 0.05 0.07 0.10 0.12 0.14 0.25 0.29 0.32 0.36 0.40 0.43 0.47 0.50
AP Hand 0.02 0.04 0.05 0.07 0.09 0.11 0.19 0.22 0.25 0.27 0.30 0.32 0.35 0.38
Lat Hand 0.03 0.05 0.09 0.12 0.15 0.18 0.21 0.24 0.35 0.39 0.43 0.46 0.50 0.54
Femur 0.04 0.08 0.13 0.17 0.21 0.25 0.30 0.34 0.38 0.43 0.46 0.51 0.55 0.59
Knee 0.04 0.08 0.13 0.17 0.21 0.25 0.30 0.34 0.38 0.43 0.46 0.51 0.55 0.59
Ankle 0.02 0.05 0.07 0.10 0.12 0.14 0.25 0.29 0.32 0.36 0.40 0.43 0.47 0.50
AP Foot 0.02 0.05 0.07 0.10 0.12 0.14 0.25 0.29 0.32 0.36 0.40 0.43 0.47 0.50
Lat Foot 0.03 0.05 0.09 0.12 0.15 0.18 0.21 0.24 0.35 0.39 0.43 0.46 0.50 0.54
4 ACR-SPR Practice Guideline for General Radiography. ACR Practice Guidelines and Technical Standards for 2013.American College of
Radiology. Reston, VA.
27
4.12 Pediatric Dose Value Chart
Typically, dose value is proportional to the quality of the images obtained. Appropriate
considerations should be made for pediatric patients to assure appropriate dose is
maintained based on mAs settings.
28
5.0 Battery Replacement and Care
5.1 Battery Replacement
A flashing, red Low Battery indicator located on the control panel and intermittent
audible signal indicate the need for a freshly charged battery. The NOMAD MD cannot
emit X-rays with a low, depleted battery with insufficient voltage. Follow these steps to
clear the Low Battery alert:
Carefully insert a newly charged battery into the base of the NOMAD MD handle. (A
properly oriented battery should click into place without force; forcing the battery into
position may damage the battery and/or the device.) A clicking sound ensures that the
snaps on both sides of the handle bottom are fastened. Make sure the battery is secure by
giving it a tug. When a battery is detached and then reattached or when a new battery is
attached, the most recently entered exposure time is shown on the numeric display, after
first disengaging the security lock.
After the initial 30 to 45 minute recharge, the charger will switch to Tune-Up Mode,
which continues for 8 hours while cells in the battery are equalized. The battery is ready
for use and can be removed at any time during Tune-Up Mode. Always unplug the
charger from the power supply when it is not in service. For additional info specifically
about the charger, see the accompanying instruction manual for the battery charger.
Battery charge will diminish during extended inactivity. Fully recharge batteries every 3
months during inactivity. Never place a low battery into long-term storage.
29
• Replace the battery immediately if it does not retain a charge during normal operation
or if there are any signs of deterioration.
• Do not drop the batteries since mechanical shock can damage the batteries and can
initiate battery failure.
• The batteries contain no user serviceable parts. Opening the battery enclosure will void
the warranty.
• Do not pierce the plastic enclosure (no nails, screws, or other sharp metal objects).
Risk of Shock: There is high electrical current present at the battery charger terminals.
Do not probe with fingers or conductive objects.
The following are instructions for handling a product at end of life. Please, protect the
environment and do not improperly dispose of any part of the NOMAD MD system,
battery, or charger; contact an authorized distributor or Aribex, regarding assistance in
returning the product for proper disposal. Please fully discharge and properly package
batteries before returning to Aribex for disposal (see the accompanying instruction
manual about the batteries for proper packaging guidelines).
Cd
30
6.0 NOMAD MD Care and Upkeep
6.1 Alarms and Alerts
The visual and audible alarms signal a programmed action designed to prevent harm to
the operator, patients, and/or the NOMAD MD.
The visual/audible alerts confirm normal conditions or draw the operator’s attention to a
required action.
OH
power on and continue with
Alarm exposures (see Section 2.3 Usage
and Duty Cycle).
Low Battery Red Low Battery Replace the battery and reset
indicator flashes Slow series of short exposure time (for information see
beeps Section 5.0 Battery Replacement and
Alert Care).
31
Condition Visual Audible Function/
Indicator Signal Resolution
Invalid
Input Error Invalid input (for example, triggering
N/A Two short beeps prior to enabling) activates alert,
which then ends automatically.
Alert
Valid Input For numeric LED
display, time setting Valid when panel button is pressed
Single short beep
increments or or released.
Alert decrements
System Alert LED display turns off Two short beeps X-ray emissions are not detected
during timed exposure because there
has been a failure in the internal
Alert Followed by a system shutdown circuitry. The battery may be OK.
Power ON
Power button is pressed and
LED display lights up Single long beep
released (while power is off).
Alert
6.2 Troubleshooting
If you encounter results and/or errors in the operation of the NOMAD MD that are not
explained in the previous sections, check the following table on user troubleshooting to
determine the need for authorized service. If you have additional questions or require help,
contact Aribex customer support by emailing support@aribex.com or calling 1-866-340-
5522.
32
Device Symptom Potential Problem Corrective Action
Combined movements of Check the exposure time setting
6.2.2 Image from X-ray operator and patient during and re-enable when operator
exposure is blurred. exposure produced too much and patient are again properly
distortion. situated.
6.2.3 Green Enabled The NOMAD MD is no longer
Check the exposure time setting
indicator stops flashing (and enabled. If an X-ray exposure is
and re-enable when operator
corresponding, short double not initiated within 20 seconds
and patient are again properly
beeps end) before an of enabling, the system ready
situated.
exposure is started. condition will terminate.
6.2.4 Green Start and yellow Incomplete exposure – the This condition is cleared
X-rays On indicators flash depressed trigger was released automatically within 10 seconds
(with corresponding series of before the timed exposure was or by manually turning the
long beeps). able to complete. NOMAD MD off and back on.
No exposure – a subsequent low Follow proper procedures
battery alert will signal whether for replacing the battery; see
a low battery is the source of the Section 5.0 Battery Replacement
problem. and Care.
6.2.5 Yellow X-rays On
indicator does not illuminate. If within a few seconds, two
short beeps are emitted and The NOMAD MD will require
the system automatically shuts authorized service; see Section
down, a different problem 7.0 Maintenance and Repair.
exists.
After about 2.5 minutes of
inactivity, the NOMAD MD emits Manually turn on the NOMAD
two short beeps and shuts off MD when you are ready to use
automatically – the system has the device.
6.2.6 The NOMAD MD timed out.
automatically shuts down. However, if while attempting an
X-ray exposure two short beeps The NOMAD MD will require
were emitted and shutdown authorized service; see Section
occurred, a different problem 7.0 Maintenance and Repair.
exists.
33
Device Symptom Potential Problem Corrective Action
Ensure battery is securely
attached.
If pressing Power several times
does not cause the numeric Replace with a newly charged
(LED) display to illuminate, the battery before continuing. Use
attached battery is likely the the battery charger to determine
problem. if the first battery is spent and
6.2.7 There is no power to the must be taken out of service or
NOMAD MD control panel. if it can be recharged.
If while attempting an X-ray
exposure two short beeps were
The NOMAD MD will require
emitted and shutdown
authorized service; see Section
occurred, a different problem
7.0 Maintenance and Repair.
exists (see Section 6.1 Alarms
and Alerts).
Be sure to align the red laser
Either red laser dot was not
dot with the middle of the
properly aligned with the reticle,
6.2.8 X-ray image is not reticle before taking the X-ray
or the area being X-rayed was
centered on target area. exposure; also be sure to align
not aligned on the center of the
the area being X-rayed on the
receptor.
center of the receptor.
To unlock control panel after
6.2.9 Even though the having powered up the NOMAD
NOMAD MD is powered on, The NOMAD MD control panel MD, press the upper left and
control panel buttons are is locked. lower right exposure time
unresponsive. buttons simultaneously and hold
for 2 seconds.
Wait for the countdown
6.2.10 The LED display begins
The NOMAD MD has sequence to complete; then
to alternately flash “OH” and
overheated. power on and continue
a countdown sequence.
exposures.
If you have additional questions or require help, contact customer support by emailing
support@aribex.com or calling 1-866-340-5522.
34
7.0 Maintenance and Repair
7.1 Maintenance Schedule
The following quality checks and maintenance items can be performed by any trained
personnel. Use Section 7.3 Maintenance Log Sheets to track results.
On-going Maintenance:
1. Schedule the NOMAD MD for a maintenance inspection at Aribex every five years.
2. Periodically review Section 1.1 Intended Use/Indications for Use and product labeling
in order to verify understanding of indications for use for the NOMAD MD.
4. Batteries should be replaced every 1–2 years or as needed. If during the normal course
of use battery charge depletes after 10–20 exposures (i.e., 25% of expected exposures
for a fully charged battery), replace the battery.
6. Periodically review the technique, dose value, and dose area product charts on page
24 through page 28 for comprehension and to assess whether or not chart
information is being incorporated into daily use.
7. Periodically review Section 2.1 Radiation Safety and Section 2.2 Studies and Data on
Leakage and Scatter in order to become reacquainted with safety precautions, which
include designating a Significant Zone of Occupancy and understanding exposure
information near the unit.
Annual Maintenance:
1. Power Button Verification: Verify that the Power button is working properly and
that the exposure time selection LED is illuminated and that an indicator alarm sounds
when the device is powered on.
2. Lock-out Mode Verification: Verify that the device is in lock-out mode when the
device is initially powered on. Press the upper left and lower right exposure time
buttons simultaneously, holding them down for approximately 2 seconds to unlock the
device. Verify that the device is unlocked.
3. Automatic Shut-off Verification: Verify that, when left on for a period of approximately
35
2.5 minutes without pressing any buttons, the device automatically shuts off.
4. Time Exposure Buttons Verification: With the device powered on and unlocked,
verify that a time selection value indicates on the user interface panel. Also check the
function of the time exposure buttons. Pressing the time exposure buttons should cause
the LED display to adjust accordingly.
5. Enable and Start Buttons Verification: Verify that the Enable and Start buttons
on the user interface panel are functioning properly. Also verify that the Enabled and
Start LEDs illuminate when their corresponding buttons are pressed.
6. Trigger Verification: Verify that the trigger moves freely when depressed and released.
7. SSD Cage Verification: Verify that the cage is firmly attached to the collimator cone
and that it is not cracked or broken.
8. Shutter Rings Verification: Verify the function of the shutter rings. The ring with the
larger tabs furthest from the operator moves the outer shutters to adjust the horizontal
size; the ring with the smaller tabs closest to the operator moves the inner shutters
to adjust the vertical size. Rotating tabs clockwise closes the shutters; rotating tabs
counterclockwise opens the shutters.
10. Exposure Termination Verification: Select an exposure of 0.99 seconds using the
time exposure buttons. Initiate an exposure, but release the exposure switch before
0.99 seconds have elapsed. Verify that the exposure terminates immediately upon
release of the trigger.
11. Laser Range Indicator Verification: Verify that the laser range indicator is properly
calibrated by placing the device 28 inches from a flat wall or surface and enabling the
device. Verify that a white rectangular light field with a black reticle and a red laser
dot appear on the wall. If the device is 28 inches from the wall, the red dot should be
positioned approximately in the center of the reticle.
12. Light Field Size Verification: With the device positioned 28 inches from the wall,
adjust the shutters until they are fully open. Enable the device and measure the light
field that is displayed on the wall. It should measure approximately 10 inches x 12
inches (25.4 cm x 30.48 cm).
13. Image Size Verification: With the device positioned 28 inches from a panoramic film
or digital plate, adjust the shutters until they are fully open. Take an exposure. Verify
that the resulting image is approximately 10 inches x 12 inches (25.4 cm x 30.48 cm).
14. X-Rays On LED and Audible Signal Verification: While taking the exposure to
verify the x-ray beam size, verify that the X-Rays On LED illuminates and the audible
signal is heard.
15. Operator Manual Verification: Ensure that the operator of the system has received a
copy of the operator manual.
36
• The NOMAD MD should not be operated if it has been dropped, if performance
degrades, if the SSD cage has been broken or compromised in any way, or if the
light field fails to function; it should be returned to Aribex for an evaluation.
• Fully charge the battery before placing it into long-term storage (over 30 days).
After placing the battery into long-term storage, it is recommended that the battery
be fully recharged every 3 months.
• The NOMAD MD and the battery charger are NOT designed to be user serviceable.
Do not open the device housing. Doing so will void the warranty.
Set up a calibrated Performance Meter (such as the Fluke TNT 12000) according to
manufacturer’s specifications to detect and report the following: X-ray Tube Voltage (kVp
average and kV PPV), Radiation Time (ms Effective Mode), and Dose (mR Average Mode).
Measurement Method: Final performance measurements are made using a Fluke TNT
12000. Exposure time is measured from the moment X-rays are detected until they are
no longer detected (which means 90% crossing setting is selected with no timer delay).
Accelerating voltage (kV) is calculated using kVp average and kV practical peak value (kV
PPV). Linearity is calculated per IEC60601-2-7, 50.102.2a.
This X-ray unit may be dangerous to testing technician and any bystanders unless safe
test exposure factors, such as placing the test detector in a lead lined box or the use
of an apron (with 0.5mm lead equivalent) and thyroid collar, are observed. Safety
equipment used with this device should be fully tested and certified, and CE marked for
compliance with the EU PPE Directive.
Enable the NOMAD MD and with the collimator perpendicular to the test detector, make
exposures into the test detector and capture the resulting data.
Compare the result with the factory release parameters (indicated in the chart below). For
results outside these parameters, discontinue use and contact Aribex.
A duty cycle of 1:60 is required after each x ray discharge to prevent over-heating
damage to the x ray tube.
37
7.3 Maintenance Log Sheets
Inspection at Aribex
5. Enable and Start Buttons
6. Trigger
7. SSD Cage
8. Shutter Rings
9. Inclinometer
10. Exposure Termination
11. Laser Range Indicator
12. Light Field Size
13. Exposure Size
14. X-Rays On LED and Audible Signal
15. Operator Manual
16. Calibration Checks (Optional)
Inspection at Aribex
5. Enable and Start Buttons
6. Trigger
7. SSD Cage
8. Shutter Rings
9. Inclinometer
10. Exposure Termination
11. Laser Range Indicator
12. Light Field Size
13. Exposure Size
14. X-Rays On LED and Audible Signal
15. Operator Manual
16. Calibration Checks (Optional)
38
7.4 Repair
Repairs can only be undertaken by trained service personnel. Direct all questions to Aribex
toll free: 1-866-340-5522; fax 800-659-4299.
The following are instructions for handling a product at end of life. Please, protect the
environment and do not improperly dispose of any part of the NOMAD MD system,
battery, or charger; contact an authorized distributor or Aribex, regarding assistance in
returning the product for proper disposal. Please fully discharge and properly package
batteries before returning to Aribex for disposal (see the accompanying instruction
manual about the batteries for proper packaging guidelines).
Cd
39
8.0 Technical Description
8.1 Basic Technical Specifications
Maximum deviation from fixed factors: ±10% (unless otherwise noted)
Total weight: 5kg (11 lbs)
Environmental
Operation
Temperature –5°C to +40°C (+23°F to +104°F)
+4°C to +40°C (+39°F to +104°F) charging
Relative humidity 10% to 80%, non-condensing
Storage and transportation
Temperature –20°C to +60°C (–4°F to +140°F) NOMAD
–20°C to +40°C (–4°F to +104°F) battery
Relative humidity 95%, non-condensing
Do not use the NOMAD MD device outside of the temperature and relative humidity
ranges specified.
Electrical
Rechargeable NiCad battery 14.4V, 2A/hr
Low battery alert set point 14.4V
Battery current at 2.0mA, 75kVp output approx. 26A
40
X-ray Controls and Generator
Maximum output power 150W nominal at 75kV, 2.0mA
Generator rating 2.0mA at 75kVp ±10%
Leakage technique factors 75kV, 2.0mA, 0.99 sec.
Collimator Cone
Minimum source to skin distance 30cm (from focal spot to SSD tip)
Nominal dose output at SSD tip (30cm) 3.28mGy/sec.
X-ray field size and Max: 106.6 x 133.3 mm
configuration Min: 13.12 x 13.12 mm
Shielding Primarily non-lead heavy metals in molded
plastic. Some lead is added as needed to
reduce radiation leakage.
Laser
Safety classification Class 2
Wavelength 655 nm
Maximum power <1 mW
Beam divergence 2 mrad
41
8.3 X-ray Tube Specifications and Characteristics
The KL 11-0.4-70 is available for nominal tube voltage with self-rectified or constant
potential circuit – manufactured by Kailong.
Nominal tube voltage 50 – 70kV
Nominal focal spot (IEC 60336:1993) 0.4mm
Maximum anode heat content 4500J
Maximum current continuous service 1.5mA x 70kV
Maximum anode cooling rate 100W
Nominal anode input power 430W
Target material Tungsten
Minimum target angle 12˚
Filament characteristics 2.2 – 3.0A, 2.0 – 3.5V
Minimum permanent filtration (IEC 60522:1999) 0.8mm Al/50kV
y M4Deep10
37
CENTRAL X-RAY
100MIN 12°
F
Ø30MAX
C C
F
Ø12
F: FILAMENT
C: CATHODE 10MAX 70 2MIN
OUTLINE DRAWING
x axis: horizontal y axis: vertical
42
Cathode Emission/Filament Characteristics Chart
Rating Chart
43
8.4 EMC Data
Independent laboratory testing for electromagnetic compatibility for conformity to the
Sub-clause 5.10 requirements of ISO/IEC 17025 “General Criteria for the Competence of
Testing and Calibration Laboratories” was conducted by:
The NOMAD MD needs special precautions regarding EMC and needs to be put into
service according to the EMC information provided in this manual.
The NOMAD MD X-ray system is intended for use in the electromagnetic environment
as specified. The NOMAD MD uses RF energy only for its internal function. In addition,
the housing includes conductive shielding; therefore, while portable and mobile RF
communications equipment can affect other medical electrical equipment, the RF
emissions of the NOMAD MD are very low and are not likely to cause any interference in
nearby electronic equipment.
The NOMAD MD is intended for use by healthcare professionals only. This system may
cause radio interference or may disrupt the operation of nearby equipment. It may be
necessary to take mitigation measures, such as re-orienting or relocating the NOMAD
MD or shielding the location.
The test results show that the NOMAD MD is suitable for use in all establishments,
including domestic establishments and those directly connected to public low-voltage
power supply networks that supply buildings used for domestic purposes. Test Report
Serial No. 226889-3.2 verifies that the NOMAD MD passed all necessary testing, and
is compliant with the following standards, as they are applicable for the device type: EN
60601-1-2:2007, EN 55011 (2007), IEC 61000-4-2 (2008), IEC 61000-4-3 (2006), IEC
61000-4-4 (2004), IEC 61000-4-6 (2008), and IEC 61000-4-8 (1993). A complete copy of
the test report will be made available to the appropriate parties upon request.
44
8.5 Limited Warranty
LIMITED WARRANTY
COVERAGE. Aribex warrants its medical and dental x-ray equipment to be free from any defects in
material or workmanship for a period of one (1) year from the date of purchase. Aribex also warrants
any accessories purchased from Aribex to be free from any defects in material or workmanship for the
period of one (1) year from the date of purchase.
The liability of Aribex is limited to repair or replacement of any parts that Aribex or its authorized
resellers determine to be defective. Contact Aribex for a Return Authorization (RA) number and shipping
instructions. Parts proving defective shall be repaired or replaced free of charge (labor and shipping
included), if defective equipment is returned (shipment return service) to Aribex (USA) or the location
of the authorized service center. Equipment repaired or replaced under warranty shall continue to be
warranted for the balance of the original warranty term. All warranty claims must be made not later than
ten (10) business days following the expiration of the applicable warranty period.
LIMITATIONS OF COVERAGE. This warranty does not apply to equipment that is or has been abused,
misused, or altered (including opening enclosure or tampering), improperly maintained, subjected to use
beyond rated conditions, or damaged as a result of any carelessness or accidents. This warranty does not
cover ordinary wear and tear or maintenance.
LIMITATIONS OF LIABILITY. Aribex makes no other warranty, either expressed or implied, with respect
to any equipment purchased from Aribex, including without limitation any implied warranties of
merchantability or fitness for a particular purpose, whether or not Aribex may have been informed of
the actual uses to which any of such equipment may be put. Aribex shall not under any circumstance be
liable for incidental, indirect, consequential, punitive or exemplary damages, including without limitation
damages for delay or lost profits, and in no event shall liability of Aribex arising from the purchase, sale
or use of the equipment, or breach of any warranty made above, exceed in the aggregate the purchase
price paid therefore.
45
NOTES
46
NOTES
47
0473
© Aribex 2015
All Rights Reserved
English is the original draft language for this manual.