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Handheld X-ray System

for Medical Radiographic Imaging

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.

Further information about Aribex intellectual property available: aribex.com


The symbols used in this publication or used to mark the equipment have the
following meanings:

Ionizing Radiation

Attention, consult instructions for use

Laser Radiation: Class 2 laser product, do not stare into beam

Recycling/instructions for handling product at end of life


Cd

Dangerous Voltage, Electrical Shock Hazard

Manufacturer of the device

Date of device manufacture

REF Model number or corresponding name

SN Unique serial number for the device

Reference to a radiation filter or a value of filtration

Type B Equipment (providing a degree of protection against


electric shock, pertaining particularly to allowable leakage
currents)
Conformity marking indicating that product meets
requirements to be sold in the European Union (EU)

Marking indicating that product is compliant with certain


North American safety standards

Power button, used to power on/off device

Audible signal, indicating audible cues emitted by device


during operation

EC REP Indicates manufacturer’s authorized representative in the EU


Table of Contents
1.0  Getting Started 6
1.1  Intended Use/Indications for Use 6
1.2  Unpack, Check, and Register NOMAD MD System 6
1.3  Charging the Batteries 7
2.0  Safety Precautions 9
2.1  Radiation Safety 9
2.2  Studies and Data on Leakage and Scatter 11
2.3  Usage and Duty Cycle 14
2.4  Cleaning  14
2.5  Security, Storage, and Transportation 14
3.0  Setup and Check 16
3.1  Attaching a Charged Battery 16
3.2  Checking for Power and Adequate Charge 16
3.3  Optional Checks 17
4.0 Operation 18
4.1  Powering Up 18
4.2  Ensuring the Right Exposure Time Is Set 18
4.3  Preparing to Enable the Device  19
4.4  Situating the Patient and Enabling the Device 20
4.5  Initiating and Completing an X-ray Exposure 22
4.6  Powering Down 22
4.7  Exposure Techniques 22
4.8  Adult Technique Chart 24
4.9  Adult Dose Value Chart 25
4.10  Adult Dose Area Product Chart 25
4.11  Pediatric Technique Chart 26
4.12  Pediatric Dose Value Chart 28
4.13  Pediatric Dose Area Product Chart 28
5.0  Battery Replacement and Care 29
5.1  Battery Replacement 29
5.2  Battery Care 29
6.0  NOMAD MD Care and Upkeep 31
6.1  Alarms and Alerts 31
6.2 Troubleshooting 32
7.0  Maintenance and Repair 35
7.1  Maintenance Schedule 35
7.2  Optional Calibration Checks 37
7.3  Maintenance Log Sheets 38
7.4 Repair 39
8.0  Technical Description 40
8.1  Basic Technical Specifications 40
8.2  Functional Diagram  41
8.3  X-ray Tube Specifications and Characteristics 42
8.4  EMC Data 44
8.5  Limited Warranty 45
Thank you for choosing the NOMAD MD TM
as your X-ray solution!

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.

NOMAD MDTM Features:


• Performance – Battery power source delivers dependable high voltage (75kV, true DC)
and direct current (2.0mA).

• Consistent Emission Radiation – High-frequency, constant-potential X-ray generator


provides high quality images, with a lower radiation dose to the patient than standard
AC X-ray systems. (See Compendium Report, May 1993, Vol. XIV, No. 5, “X-Radiation:
Potential Risks and Dose Reduction Mechanisms.”)

• Radiation Protection – Operator shielded from source radiation.

• Simple Operation – Operator custom-selects exposure time, shutter width, and


shooting distance, all to ensure precise X-rays; exposure time digitally displayed on the
user-friendly control panel along with indicators for machine and battery status.

• Exposure Thickness Range – Validated to capture diagnostic quality images of body


part extremities such as fingers (from 1.5cm) and thighs (up to 21cm).

• Lightweight and Ergonomic – Design provides complete flexibility and convenience,


allowing operator to perform exposures without moving patients.

• 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.

• Inclinometer – Inclinometer attached to side of device provides method for measuring


angles during exposure process.

• 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.

1.2  Unpack, Check, and Register NOMAD MD System


 Unwrap individual components from the protective plastic and check for any
noticeable signs of damage. The standard package system includes the following items:

• NOMAD MD Device with SSD (Source to Skin Distance) cage and integrated
inclinometer attached

• Two Rechargeable Batteries

• Battery Charger (the charger should be appropriate for local AC line voltage; actual
color/style/model may differ)

• Certificate of Conformance, Getting Started Guide, Battery Charger Manual,


Warranty/Registration Card, and NOMAD MD Operator Training DVD
SSD Cage
Inclinometer
Getting Started Guide

Certificate of Conformance

Battery Charger Manual

Warranty/Registration Card Batteries:


Charge Before
Use
Operator Training DVD
Battery Charger

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 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.

1.3  Charging the Batteries


NOTE: Batteries are charged at the factory and should be fully recharged before the initial
use of the NOMAD MD. If the system has been in long-term storage prior to initial use,
batteries will definitely require a proper charge first. Actual color/style/model of batteries
may differ from batteries shown in manual pictures.

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).

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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.

 Invert one of the batteries and carefully


plug it into the charger (do not force the
battery into the charger or the battery may
be damaged as a result). The red indicator
light on the top of the charger will flash at
a steady rate while the battery is charging.
The required charge time varies (normally
between 30 to 45 minutes). Battery and
charger may become warm to the touch while
charging, which is a normal condition.

 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.

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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.

• Operators must be fully


acquainted with industry safety recommendations, established maximum permissible
doses, and local jurisdiction requirements for use. Beyond these requirements and the

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instructions provided by Aribex, no additional
skills, training, or knowledge are required.

• Do not enable the NOMAD MD until the


patient and operator are positioned and ready
for the exposure, preventing interruption and
inadvertent exposure of anyone to X-rays.

• An exposure can be terminated for any reason


by prematurely releasing the depressed
trigger (for more information, see Section 4.0
Operation).

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.

In implementing a radiation protection program, consult all applicable regulations


governing radiation protection and the use of X-ray equipment, and ensure full
compliance with any such regulations.

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2.2  Studies and Data on Leakage and Scatter
Besides direct beam, potential exposure from X-ray devices has only two other possibilities:

1) leakage radiation and


2) scatter radiation from the patient/subject in the direct beam.

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

X-ray Source Recommended patient


Focal Spot buffer plane
Primary SSD Cage
Protective
Shielding
Source to Skin Distance
Rechargeable (min. 30 cm)
Battery

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)

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90

80

Chart 1: Vertical Axis, 60 cm X 200


70 cm

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

Foot Phantom and DR 41 - 80 μGy/hr


Plate

> 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:

Duration  0.25 sec  0.46 sec  0.50 sec  0.99 sec


Cycle  Every 15 sec  Every 28 sec  Every 30 sec  Every 60 sec

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.

Do not spray disinfectant or cleaners directly on the NOMAD MD or battery charger.


The connecting areas are open to ingress and damage to your device may result.

2.5  Security, Storage, and Transportation


• Do not store the NOMAD MD, battery charger, or batteries in extreme conditions:
below –20°C (–4°F) or above +60°C (+140°F) for the device or above +40°C (+104°F)
for the batteries, or beyond 95% relative humidity (non-condensing). The optimal
storage location is cool, dry, and away from direct sunlight. For more info about
storage and operational temperature limits, see Section 8.1 Basic Technical Specifications.

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• 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).

• The NOMAD MD must be kept in a secure location


(such as a locked cabinet) when not in use in order
to prevent unauthorized access.

• The battery serves as one of the device security


keys. When finished with the NOMAD MD for the
day, detach the battery and lock it away in a
separate location to prevent unauthorized use.

• Another one of the security keys of the device is the lock-out


feature. If the NOMAD MD has automatically shut off after
a 2.5 minute period of inactivity or if it has been turned off
manually, simply pressing the Power button alone will
NOT allow the operator to begin the enable sequence. The LC
operator must first press the Power button and then
press the upper left and lower right exposure time buttons
simultaneously, holding them down for approximately 2
seconds.

• Take steps to ensure the NOMAD MD is in a secure


location when not in use. Lay it on its side if necessary.
Power will automatically shut off after a period of inactivity
(approximately 2.5 minutes). Disengaging the
lock-out feature
• Do not store or carry batteries so that metal objects can
contact exposed battery terminals.

• Some battery charge may


be lost during extended
inactivity (leading to
fewer exposures between
charging periods). The Enable button
batteries may also
completely lose charge
if they are left in the
device for over a week.
If the NOMAD MD is
not likely to be used for
an extended period, the
75kV - 2.0mA Low battery
indicator
THIS X-RAY UNIT MAY BE DANGEROUS TO PATIENT

battery should be removed AND OPERATOR UNLESS SAFE EXPOSURE FACTORS,


OPERATING INSTRUCTIONS AND MAINTENANCE
SCHEDULES ARE OBSERVED.

from the device.

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.

3.0  Setup and Check


3.1  Attaching a Charged Battery
 Properly orient and carefully insert the 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.) The clicking
sound ensures the snaps on both sides of the handle bottom are fastened.

 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.

3.2  Checking for Power and Adequate Charge


 After inserting a fully charged battery, press, hold briefly, and
then release the Power button on the user interface panel.
The numeric (LED) display should illuminate, showing an “LC”
(an indication that the security lock is engaged), accompanied
by a single, elongated audible signal . Then, simultaneously LC
press the upper left and lower right exposure time buttons and
hold them for 2 seconds. If the security lock has been successfully
disengaged, the most recently entered exposure time will show
on the numeric display. If the “LC” remains on the display, try
pushing the exposure time buttons again, this time being sure to
hold down for a full 2 seconds.

 In order to check whether or not the NOMAD MD has


sufficient battery charge to complete an exposure, enable the Disengaging the
device by either pressing and releasing the Enable button or lock-out feature
pressing and releasing the trigger.

 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.

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 For continued use, insert the secondary, replacement battery (which should be
charged in advance).

3.3  Optional Checks


The NOMAD MD is factory calibrated and tested prior to release (see your Certificate of
Conformance); the only adjustment options are length of exposure and X-ray field size.
However, the optional checks listed below may be performed by a qualified technician as
desired.

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.

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.

See Section 6.1 Alarms and Alerts, for more information.

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.

Press, hold briefly, and then release the


Power button to turn on the NOMAD MD.
The numeric (LED) display should illuminate,
showing an “LC” (an indication that the security
lock is engaged), accompanied by a single,
elongated audible signal . The illuminated
display and audible signal indicate the unit
has power. Press the upper left and lower
right exposure time buttons simultaneously 75kV - 2.0mA

and hold for 2 seconds in order to disengage


THIS X-RAY UNIT MAY BE DANGEROUS TO PATIENT
AND OPERATOR UNLESS SAFE EXPOSURE FACTORS,
OPERATING INSTRUCTIONS AND MAINTENANCE
SCHEDULES ARE OBSERVED.
the security lock. (After approximately 2.5
minutes of inactivity, the NOMAD MD shuts Powering On and Unlocking the
off automatically and can only be activated NOMAD MD
by pressing the Power button and
disengaging the security lock.)

4.2  Ensuring the Right Exposure Time Is Set


When the power is turned off, the most recent setting for exposure time is stored in the
memory and redisplays when the power is turned back on and the security lock is
disengaged.

To change exposure settings, press


the increase or decrease buttons.
(Exposure time increases and
decreases by tenths and hundredths
of a second. Following is an example Increase
of how to read the display: 08 LED buttons
setting = 0.08 seconds; 35 LED
setting = 0.35 seconds.) A single,
short audible signal confirms
input when a button is pressed and
released. To scroll through exposure 75kV - 2.0mA
time settings, press and hold on the THIS X-RAY UNIT MAY BE DANGEROUS TO PATIENT
AND OPERATOR UNLESS SAFE EXPOSURE FACTORS,

appropriate increase or decrease


OPERATING INSTRUCTIONS AND MAINTENANCE

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.

The shutters located at the end of the


collimator determine the size of the X-ray
field. The shutters are controlled by the two
tabbed rings located on the outside rim
of the collimator cone. The ring with the
larger tabs furthest from the operator moves Opens Shutters
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. Closes Shutters

The inclinometer attached to the left side


of the NOMAD MD is used to measure the
angle of the device relative to the earth.
Even before enabling the NOMAD MD,
you can determine which angle will be best
suited for the exposure being taken.

As much as possible, determine device


angle, shutter dimensions, and appropriate
distance from the patient prior to enabling
the device. More precise adjustments can
be made after enabling the device, but
preliminary inputs are suggested.
Inclinometer

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.

There are two ways to ready the device for


exposures: either press and release the
Enable button, or press and release the
trigger. Be sure to re-enable the NOMAD
MD if any subsequent changes are made to
the timer setting prior to exposure.

The flashing, green Enabled indicator and


audible signal (an intermittent, double 75kV - 2.0mA
beep) confirm that the NOMAD MD is THIS X-RAY UNIT MAY BE DANGEROUS TO PATIENT
AND OPERATOR UNLESS SAFE EXPOSURE FACTORS,
OPERATING INSTRUCTIONS AND MAINTENANCE

enabled. This continues for 20 seconds or SCHEDULES ARE OBSERVED.

until an exposure is initiated.


Indicates device is enabled
If the red Low Battery indicator flashes, Indicates device has low battery
accompanied by an intermittent audible
signal , see Section 3.2 Checking for
Power and Adequate Charge and Section 5.0 Battery Replacement and Care.

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.

Upon enabling the device, expect to


see two colored projections on the
patient: a white rectangular light
field with a black reticle and a red
laser dot. The light field indicates
the area of the patient that will be
exposed to X-rays; to reduce patient
dose, the field size should be
collimated to the minimum possible
area required to produce the
desired diagnostic image. The red
laser dot can be moved either up
or down on the reticle: moving the
device away from the patient causes
the laser to travel vertically up the
reticle, while moving the device
towards the patient causes the laser
to travel vertically down the reticle.

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.

When the X-ray source is 28 inches (71.12 cm)


from the patient and the shutters are fully open, Reticle image and measurements
the X-ray field size is 10 inches x 12 inches (25.40
cm x 30.48 cm).

Location of laser aperture


(top: full view, left: close-up
view)

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 generate the exposure, press and hold the


handle trigger (or press and hold Start). The
Enabled indicator stops flashing, and the
green Start and yellow X-rays On indicators
illuminate.
75kV - 2.0mA

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

or Start button depressed until the audible,


SCHEDULES ARE OBSERVED.

continuous-tone signal ends and both the


X-rays On and Start indicators are off. Indicates exposure is in process

4.6  Powering Down


Press and release Power button to turn the NOMAD MD off, or wait for it to
automatically shut off after approximately 2.5 minutes of inactivity.

4.7  Exposure Techniques


The NOMAD MD provides a high degree of flexibility, making it
possible for exposures to be produced while patients are reclined,
lying on their backs, or sitting upright. The operator can also take a
variety of positions in relation to the patient as well as orient the
NOMAD MD using a variety of angles.

 When taking images, hold the


NOMAD MD using two hands, placing
one hand on the handle and the other
hand under the device housing for
increased stability and patient safety.

 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.

 Avoid touching the patient with the cone or SSD cage


and/or use disposable plastic coverings. The NOMAD MD
is designed and tested to be capable of operating inside a
transparent and protective bag.

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.

Adult Technique Chart


2.0 mA 75 kV
Focal-Film Distance: 28 in (71.12 cm)
400 Speed Equivalent Imaging System

Thickness of Part in Centimeters

Extremity 1.5 3 4.5 6 7.5 9 10.5 12 13.5 15 16.5 18 19.5 21

Estimated Exposure Time in Seconds

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.

Adult Dose Values for NOMAD MD


Exposure Time in Dose Value in Exposure Time in Dose Value in
Seconds Micrograys Seconds Micrograys

0.02 5.8 0.05 12.3


0.10 23.4 0.15 34.2
0.20 45.4 0.25 56.3
0.30 67.1 0.35 78.3
0.40 89.2 0.45 100.2
0.50 111.2 0.55 122.3
0.60 133.1 0.65 144.1
0.70 154.9 0.75 166.1
0.80 177.0 0.85 188.0
0.90 199.0 0.95 210.1
0.99 218.9

4.10  Adult Dose Area Product Chart


Dose value is measured using a Fluke TNT 12000D performance meter with a Dosemate
diagnostic ion chamber (100 cm²), with a collimated beam of 5cm x 5cm.

Adult Dose Area Product (area of 5 cm x 5 cm) for NOMAD MD


Exposure Entrance Dose Value Exposure Entrance Dose Value
Time in Dose Value per cm2 Time in Dose Value per cm2
Seconds in Micrograys (5cm x 5cm Seconds in Micrograys (5cm x 5cm
square/25 square/25
cm) cm)
0.02 1.51 37.80 µGy 0.05 3.31 82.82 µGy
0.10 4.61 115.22 µGy 0.15 8.88 221.95 µGy
0.20 9.96 248.92 µGy 0.25 15.81 395.25 µGy
0.30 18.90 472.50 µGy 0.35 19.01 475.25 µGy
0.40 22.03 550.75 µGy 0.45 27.68 692.00 µGy
0.50 30.53 763.25 µGy 0.55 33.53 838.25 µGy
0.60 35.74 893.50 µGy 0.65 39.25 981.25 µGy
0.70 42.04 1.05 mGy 0.75 44.86 1.12 mGy
0.80 47.31 1.18 mGy 0.85 49.43 1.23 mGy
0.90 52.97 1.32 mGy 0.95 55.83 1.39 mGy
0.99 58.16 1.45 mGy

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:

• Measure the body part to be imaged using calipers.

• 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.

• Review exposure indicators and image quality.

• 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.

• Ask accompanying adults beforehand if they have any questions.

• 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

Pediatric Technique Chart


2.0 mA 75 kV
Focal-Film Distance: 28 in (71.12 cm)
400 Speed Equivalent Imaging System

Thickness of Part in Centimeters

Extremity 1.5 3 4.5 6 7.5 9 10.5 12 13.5 15 16.5 18 19.5 21

Estimated Exposure Time in Seconds

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.

Pediatric Dose Values for NOMAD MD


Exposure Time in Dose Value in Exposure Time in Dose Value in
Seconds Micrograys Seconds Micrograys
0.02 5.8 0.05 12.3
0.10 23.4 0.15 34.2
0.20 45.4 0.25 56.3
0.30 67.1 0.35 78.3
0.40 89.2 0.45 100.2
0.50 111.2 0.55 122.3
0.60 133.1 0.65 144.1
0.70 154.9 0.75 166.1
0.80 177.0 0.85 188.0
0.90 199.0 0.95 210.1
0.99 218.9

4.13  Pediatric Dose Area Product Chart


Dose value is measured using a Fluke TNT 12000D performance meter with a Dosemate
diagnostic ion chamber (100 cm²), with a collimated beam of 5cm x 5cm.

Pediatric Dose Area Product (area of 5 cm X5 cm) for NOMAD MD


Exposure Entrance Dose Value Exposure Entrance Dose Value
Time in Dose Value in per cm2 Time in Dose Value in per cm2
Seconds Micrograys (5cm x 5cm Seconds Micrograys (5cm x 5cm
square/25 square/25
cm) cm)
0.02 1.51 37.80 µGy 0.05 3.31 82.82 µGy
0.10 4.61 115.22 µGy 0.15 8.88 221.95 µGy
0.20 9.96 248.92 µGy 0.25 15.81 395.25 µGy
0.30 18.90 472.50 µGy 0.35 19.01 475.25 µGy
0.40 22.03 550.75 µGy 0.45 27.68 692.00 µGy
0.50 30.53 763.25 µGy 0.55 33.53 838.25 µGy
0.60 35.74 893.50 µGy 0.65 39.25 981.25 µGy
0.70 42.04 1.05 mGy 0.75 44.86 1.12 mGy
0.80 47.31 1.18 mGy 0.85 49.43 1.23 mGy
0.90 52.97 1.32 mGy 0.95 55.83 1.39 mGy
0.99 58.16 1.45 mGy

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:

 Press and release the Power button on the control panel


in order to turn the device off.

 Grasp and depress the buttons on both sides of the battery


to release it from the handle. You may have to put pressure at the
very top of the buttons (nearest the handle). Then pull the battery
away from the handle.

 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.

5.2  Battery Care


• Battery life is expected to be between 1-2 years or 200-300 charge/discharge cycles,
whichever occurs first. When the battery charger senses a bad battery, the battery is
spent and must be taken out of service. Batteries should also be taken out of service
once only 10 to 20 exposures can be taken per charging cycle.

• Do not attempt to charge damaged or spent batteries. An authorized distributor,


Aribex, or your local recycling center will accept spent or damaged batteries. 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). Order new 14.4V batteries from Aribex or your authorized distributor. Do
not use batteries from other sources; doing so will invalidate the warranty. Check the
battery periodically (at least weekly) and ensure proper functionality.

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.

Condition Visual Audible Function/


Indicator Signal Resolution
LED display begins
alternately flashing
“OH” and a Operation suspends if the device
Overheating countdown sequence overheats; after waiting for the
countdown sequence to complete,
None

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).

X-ray Green Start and


Exposure yellow X-rays On Continuous tone (for
indicators illuminate At the end of the successful exposure,
the duration of the
audible signal and indicators stop.
timed exposure)
Alert
Incomplete Green Start and Activates if trigger is released before
Exposure yellow X-rays On the timed X-ray exposure finishes and
indicators flash Series of long beeps ends automatically after 12 seconds
or if power is manually turned off
Alert and then on.
System
Activates when Enable is pressed/
Readiness Green Enabled
Slow series of short, released; ends automatically after 20
indicator flashes
double beeps seconds or when an exposure starts
(trigger or Start is pressed).
Alert

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 OFF LED display turns off Two short beeps


Power button is pressed and
released (while power is on).
Alert Followed by a system shutdown

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.

Device Symptom Potential Problem Corrective Action


Increase the exposure time
Underexposure (too light). setting; or see “Incomplete
Exposure” below (6.2.4).
Decrease the exposure time
6.2.1 Image from X-ray
setting. Also check film
exposure does not have
Overexposure (too dark). expiration date (old film can
sufficient contrast.
produce dark, grainy/foggy
images).
Chemical developer (for film- Ensure chemical freshness and
based imaging). proper temperature.

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.

3. Clean the NOMAD MD routinely; it is recommended that the NOMAD MD device


be cleaned after any patient contact. Make sure the power is off while cleaning and
detach the battery. It is unnecessary to detach anything else in order to clean the unit.
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 surfaces, since certain chemical combinations may deteriorate the
NOMAD MD plastic prematurely.

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.

5. Periodically assess operator familiarity with the NOMAD MD to determine whether


refresher training/certification (per local, national, and jurisdictional requirements) is needed.

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.

9. Inclinometer Verification: Verify that the needle inside of inclinometer responds to


tilting of the device.

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.

7.2  Optional Calibration Checks


The NOMAD MD is factory calibrated and tested prior to release (see your Certificate of
Conformance) and there are no adjustment options. However, the optional checks listed
below may be performed by a qualified technician as desired.

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.

Test Acceptance Timer Settings and Corresponding Acceptable Ranges


Description Limits 20ms 40ms 400ms 600ms 990ms
kVp (eff) 67.5 to 67.5 to 67.5 to 67.5 to 67.5 to
75kV ±10%
Accuracy 82.5 82.5 82.5 82.5 82.5
Timer Setpoint 890 to
17 to 23 35 to 45 359 to 441 539 to 661
Accuracy ±(10%, +1ms) 1090

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

Maintenance Test Year 1 Year 2 Year 3 Year 4 Year 5 Year 6


Date/ Date/ Date/ Date/ Date/
Initial Initial Initial Initial Initial
1. Power Button

Schedule Five-Year Maintenance


2. Lock-out Mode
3. Automatic Shut-Off
4. Time Selection Buttons

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)

Maintenance Test Year 7 Year 8 Year 9 Year 10 Year 11 Year 12


Date/ Date/ Date/ Date/ Date/
Initial Initial Initial Initial Initial
1. Power Button

Schedule Five-Year Maintenance


2. Lock-out Mode
3. Automatic Shut-Off
4. Time Selection Buttons

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 factory serviceable parts and components:

• NOMAD MD, main apparatus assembly – item 0.850.0112

• SSD cage – item 0.850.0392

• Batteries – item 0.850.0068

• 110/120V AC battery charger w/ manual (DeWalt, model DW9116 or DC9310) –


item 0.850.0120

• 220/240V AC battery charger w/ manual (DeWalt, model DE9116 or DE9135) –


item 0.850.0151

• Hard-shell carrying case – item 0.850.0222

• Inclinometer – item 0.850.0117

• Laser Assembly – item 0.850.0409

• LED Assembly – item 0.850.0411

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

If product return is required, contact Aribex for a Return


Authorization (RA) number and shipping instructions to return the Serial number
product to the proper facility. You will be required to provide the location
serial number from the label affixed to the backside of the shutter
ring housing of the NOMAD MD device.

Be sure to include the RA number on the package you are


returning. Products without an RA number cannot be serviced or
given credit consideration.

Aribex will not assume responsibility for shipping damages;


however, Aribex will help you file a claim with the freight carrier.
Please see warranty information at the end of this manual.

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.

Classification / Specification Compliance


IEC 60601-1 (Ed. 3), 60601-1-3,
60601-2-7; 21 CFR 1020.30 & 1020.31 Class II, Type B
MDD (93/42/EEC): Annex IX Class IIb
IPX specification IP0; do not operate under wet conditions
Mode of operation Intermittent operation

For use in environments where no flammable anesthetics and/or flammable cleaning
agents are present. 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 surfaces, since certain chemical combinations may
deteriorate the NOMAD MD plastic prematurely.

Electrical
Rechargeable NiCad battery 14.4V, 2A/hr
Low battery alert set point 14.4V
Battery current at 2.0mA, 75kVp output approx. 26A

X-ray Controls and Generator


Exposure time range 0.02–0.99 sec.
Maximum duty cycle 1:60 (one 0.25 sec. exposure / 15 sec.)
Minimum inherent filtration 2.5mm Al

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.

Measurement Base of Technique Factors


The kV is measured during pre-potting testing using a calibrated high voltage divider
with a guaranteed accuracy of ±2%. 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).

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

8.2  Functional Diagram

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

Thermal Characteristics Chart NOTE: The X-ray source assembly


heating and cooling curves are
equivalent to the anode heating curves
shown here.

Maximum continuous heat dissipation


anode heating curves
will be made available upon request
from Aribex.

anode cooling curve

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:

Nemko CCL, Inc.


1940 West Alexander St.
Salt Lake City, Utah 84119-2039
USA

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

ISO 13485 / ISO 9001


Certified Company

© Aribex 2015
All Rights Reserved
English is the original draft language for this manual.

Aribex Phone: 866-340-5522


11727 Fruehauf Dr Fax: 800-659-4299
Charlotte, NC 28273 Email: support@aribex.com
U.S.A. http://www.aribex.com

MT Promedt Consulting GmbH, Altenhofstr. 80, 66386 St. Ingbert, Germany


EC REP
Tel: +49 6894 58102 0; Fax: +49 6894 58102 1; Email: info@mt-procons.com

0.850.0516 Rev00 09/29/15

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