KaVo NOMAD PRO 2 Operator's Manual
Handheld X-ray System
for Intraoral Radiographic Imaging
OperatOr Manual
TM
Th
ank you for choosing the KaVo NOMAD PRO 2
At KaVo 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 email
us: support@aribex.com
DO NOT OPERATE THIS DEVICE UNTIL YOU HAVE READ THIS MANUAL and reviewed the
accompanying materials.
Disclaimer: KaVo NOMAD PRO 2 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 KaVo Dental Technologies, LLC, its agents or representatives, do not accept responsibility
for:
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.
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 KaVo intellectual property available: www.kavo.com
Table of Contents
1.0 Getting Started 5
1.1 Indication for Use 5
1.2 Warnings and Precautions 5
1.3 Unpack, Check, and Register KaVo NOMAD PRO 2 System 5
1.4 Charging the Handsets 6
2.0 Safety Precautions 8
2.1 Radiation Safety 8
2.2 Studies and Data on Leakage and Scatter 10
2.3 Usage and Duty Cycle 12
2.4 Cleaning 12
2.5 Security, Storage, and Transportation 13
2.6 Product Symbols 14
2.7 Location of Device Labels 16
3.0 Setup and Power Check 17
3.1 The Backscatter Shield 17
3.2 Attaching a Charged Handset 17
3.3 Checking for Power 17
3.4 Optional Checks 18
4.0 Operation 19
4.1 Powering Up 19
4.2 Lock/Unlock the X-ray 19
4.3 Ensuring the Right Exposure Time is Set 19
4.4 Ready the Device 20
4.5 Initiating and Completing an X-ray Exposure 21
4.6 Powering Off 21
4.7 Exposure Techniques 22
4.8 Ensuring Image Quality 23
4.9 Technique Factors Settings and Adjustments 24
4.10 Settings Menu 25
5.0 Handset Replacement and Care 27
6.0 KaVo NOMAD PRO 2 Care and Upkeep 29
6.1 Alarms and Alerts 29
6.2 Troubleshooting 32
7.0 Maintenance and Repair 35
7.1 Maintenance Schedule 35
7.2 Calibration Checks 37
7.3 Maintenance Log Sheets 38
7.4 Repair 38
8.0 Technical Description 40
8.1 Basic Technical Specifications 40
8.2 X-ray Tube Specifications and Characteristics 42
8.3 Manufacturer’s Declaration 45
8.4 Cables 51
KaVo NOMAD PRO 2
KaVo NOMAD PRO 2 Handheld X-ray System is a battery-operated, portable dental X-ray
source designed for handheld operation. It is designed to produce diagnostic quality X-rays
images utilizing either film or digital imaging techniques. The KaVo NOMAD PRO 2 Handheld
X-ray System is designed for use in a dental office. It can also be used in other similar
environments (orthodontic office, general practitioner’s office, hospital ward, etc.) where
appropriate safeguards are implemented. The device uses a rechargeable battery to allow
for the use of the KaVo NOMAD PRO 2 Handheld X-ray System where transportation or use of
other x-ray devices might be prohibitive due to the other device’s size and/or lack of mobility.
The KaVo NOMAD PRO 2 Handheld X-ray System is an X-ray device with a DC generator. The
handheld device features a main unit (tube head), rechargeable battery (handset), charger,
and charger AC/DC power supply. The power is supplied by a rechargeable Lithium Ion battery
core pack built into a handset. This facilitates portability of the device. A beam-limiting cone
is incorporated within the device. Internal and external shielding provide sufficient radiation
protection to allow the clinician to remain in the operatory with the patient.
To make the system as simple as possible for the operator, KaVo NOMAD PRO 2 Handheld
Xray System uses a fixed tube voltage of 60kV and a fixed tube current of 2.5mA. The
only operator-adjustable parameter is the exposure time. This adjustment can be quickly
accomplished through the user-friendly control panel.
Control buttons, display, and a trigger provide the primary operator interface. Exposures
settings can be selected and displayed. Voltage (60 kV) and current (2.5 mA) are fixed with
the exposure time varying based on patient type, detector type, and anatomical feature.
Exposures can be completed using the trigger. The device can be used with three detector
types: film, digital imaging intraoral sensors, and phosphor plates.
Accessories supplied with the finished device include:
• Alignment bars* (Class I, Exempt, EHA, 21 CFR 872.1820)
Optional accessories:
• Rectangular collimator – rectangular and smaller exposure area
• Tabletop stand – tabletop storage
• Wall hook – storage and display
• Hard shell carrying case – protection during transportation and storage
*Alignment bars are a device for positioning image receptors and are provided as a
convenience and are not required to be used with the device.
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1.0 Getting Started
1.1 Indication for Use
The KaVo NOMAD PRO 2 Handheld X-ray System is indicated for use only by a trained
and qualified dentist or dental technician for both adult and pediatric subjects as an
extraoral diagnostic dental X-ray source to produce X-ray images using intraoral image
receptors.
1.2 Warnings and Precautions
The device is designed for use with patients of any overall health status, as solely
determined by the practitioner, with the following considerations for specific circumstances:
• Pregnant women. The medical practitioner must weigh the benefits conferred by use of
the device against the potential hazard to the pregnant woman and fetus resulting from
radiation exposure. If use of the device is considered justified, the practitioner must take
the appropriate precautions, such as use of radiation safety garments, to limit radiation
exposure beyond the maxillofacial complex.
• Pediatric. The medical practitioner must weigh the benefits conferred by use of the
device against the potential hazard to the child resulting from radiation exposure,
considering the maturity of the child’s physical development. If use of the device is
considered justified, the practitioner must take the appropriate precautions, such as use of
radiation safety garments, to limit radiation exposure beyond the maxillofacial complex.
• Patients with medical conditions causing involuntary movements. For patients who
experience seizures or who have been diagnosed with conditions such as Parkinson’s
Disease which can cause difficulty in controlling physical movements, the medical
practitioner must weigh the benefits conferred by use of the device against the potential
hazard to the patient resulting from additional radiation exposure due to a re-scan in the
event that an involuntary movement renders an image unusable for diagnostic purposes.
1.3 Unpack, Check, and Register KaVo NOMAD PRO 2 System
Unwrap individual components from the protective plastic and check for any
noticeable signs of damage. The package system includes the following items:
• KaVo NOMAD PRO 2 Devices (1.013.2040)
• Charging Cradle (1.013.2001)
• Two Rechargeable Battery Handsets (1.013.1887)
• AC/DC Power Supply (1.013.4070)
• Alignment Bars (1.010.8482)
• Certificate of Conformance, Getting Started Guide, Product Registration Card, and
KaVo NOMAD PRO 2 Operator Training CD
Preliminary Checks:
Item Check
Device Labels Verify that the serialized device label is in place (located on lower side of
unit).
Other Labels Verify that the serial number on the product registration card matches
the device serial number on the device and the device serial number on
the carrying case. Verify that the handsets’ label (located on the top of
each handset) and the charging cradle label (located on the bottom of the
charging cradle) are all in place.
Collimator Cone and
Backscatter Shield
These two items provide operator protection and should be inspected for
shipping damage.
Trigger Switch Should freely move in and out when depressed and released.
Device Housing Should be free of cracks or fractures.
Complete the product registration card and mail it with proper postage to KaVo today,
or go on-line at kavo.com/portable-x-ray-machine/warranty-registration. Registering your
device will activate your KaVo NOMAD PRO 2 Care Plan (the first year is free). For terms
and conditions of the KaVo NOMAD PRO 2 Care Plan, visit kavo.com
1.4 Charging the Handsets
KaVo NOMAD PRO 2 charging system includes rechargeable handsets, a Charging Cradle
and an AC/DC Power Supply. The AC/DC Power Supply has a removable power cord
which plugs into an AC electrical outlet (universal voltage accommodated).
Charging Power Supply
with removable power cord
Charging Cradle
• Handsets must be charged before initial use. Alternate handsets each week to
maximize service life.
• Do not spray disinfectant or cleansers directly on to the handsets.
• Do not attempt to charge below 10oC or above 40oC.
• Charge the Handsets before use and after any extended period of inactivity.
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Use only the supplied AC/DC power supply. Unwrap
the power cord of the power supply and connect it to the
charging cradle, then to an AC electrical outlet (universal
voltage accommodated). The charger will flash red lights
as it initiates, followed by a single green circle that will
illuminate to indicate there is adequate power to the
charging cradle. If the green circle does not illuminate, the
charging cradle is not receiving adequate power and may
need to be sent to an KaVo authorized service center for
repairs.
Position the charging cradle away from the normal patient environment. A plug adapter
may be needed to accommodate the local AC configuration.
Invert one of the handsets and carefully slide it onto the charging cradle (do not force
the handset onto the charging cradle or damage may result). Expect charge time to be
less than five hours. The handset, charging cradle, and
AC power supply may become warm to the touch while
charging.
When the handset is first slid onto the charging
cradle, the first bar will illuminate green for approximately
two seconds to indicate that the cradle and handset are
communicating. If the bars illuminate or flash red, see the
troubleshooting guide section 6.2.10. Authorized service
will also be required if no illumination occurs upon sliding
the handset onto the charging cradle.
After illuminating green, the first bar will begin flashing to indicate that charging has
begun. When the first bar turns solid green, the handset is 1/3 charged, and the second
bar will begin flashing green. When the second bar turns solid green, the handset is 2/3
charged, and the third bar will begin flashing green. Once the third bar turns solid green,
the handset is fully charged. Remove the handset from the charging cradle once it is
fully charged and store carefully.
Contact KaVo for Service
Receiving Adequate Power
Handset 1/3 Charged Handset Fully ChargedHandset 2/3 Charged
2.0 Safety Precautions
2.1 Radiation Safety
The KaVo NOMAD PRO 2 was designed to be used in clinical settings (e.g., a dental
office) 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,
operating instructions, and maintenance schedules are observed.
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 6 feet away from the patient. If
it is necessary for any ancillary personnel to be closer than 6 feet, these personnel
should stay out of the direct beam and wear personal protective equipment, such as
an apron and thyroid collar.
• The KaVo NOMAD PRO 2 provides a high
degree of protection from unnecessary
radiation. However, no practical design can
provide complete protection nor prevent
operators from exposing themselves or
others to unnecessary radiation. It is
important to restrict use and follow all
applicable government radiation protection
regulations. Pregnant women should not
be exposed to X-rays unless necessary.
Proper safety precautions should 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.
• Optimal operator protection from radiation
backscatter exists when the following
measures are taken:
a) the backscatter shield is positioned at the outer end of the collimator cone,
b) the backscatter shield is close to the patient,
c) the patient tilts his or her head when needed to accommodate exposures (see Section 4.7
Exposure Techniques), and
d) the operator remains within the significant zone of occupancy immediately behind the device
shield.
98
• Do not enable the KaVo NOMAD PRO 2 until patient and operator are positioned and
ready for the exposure, preventing interruption and inadvertent exposure of anyone to
X-rays.
• Do not attempt an exposure if anyone other than the patient is in the direct beam. If
others are assisting, then they should wear protective covering as required by local
jurisdictions. An apron and thyroid collar are recommended for ancillary personnel
who are closer than 6 feet to the patient.
• When selecting and using sensors, preference should be given to models that allow
the backscatter shield to remain at the outer end of the collimator cone for maximum
operator protection.
• An exposure can be terminated for any reason by prematurely releasing the depressed
trigger (for more information, see Section 4.0 Operation).
• As shown in graphic representations, maximum protection (green area) from
backscatter radiation (red area) exists when the KaVo NOMAD PRO 2 is positioned
near the patient, is perpendicular to the operator (with the patient’s head tilted if
needed), and the backscatter shield is fully extended toward the patient and parallel
to the operator.
Stay in the
ZONE
Proper Position Held Back Shield slid back Non-perpendicular
Protection:
MaxiMuM MiniMized
• Operation outside the protection zone (or with a diminished protection zone) requires
proper precautions such as the use of an apron and thyroid collar, according to
requirements of local jurisdictions.
• Do not operate if the backscatter shield or collimator cone is broken.
• For further information on the tests performed to ensure KaVo NOMAD PRO 2 safety
as a handheld device, please see Section 2.2 Studies and Data on Leakage and
Scatter.
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.
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
Unique internal shielding of KaVo
NOMAD PRO 2 encases the X-ray
tube, practically eliminating leakage
radiation. This makes it safe to use
PRO 2 as a handheld device during
exposures.
FDA regulations specify that leakage radiation from X-ray devices not exceed 0.88mGy/hr,
while IEC regulations stipulate that devices stay below 0.25mGy/hr, an even tighter limit.
In response to these regulations, KaVo will only ship product that tests below 0.88mGy/hr (at 1
meter), 0.25mGy/hr (at 1 meter), 0.02mGy/hr (at 5 cm) for leakage.
In order to verify compliance with this leakage requirement, each individual device is
tested with a calibrated survey meter at 12 points on the device housing, as shown in the
following diagram. The highest measurement out of these 12 points is reported on the
device Certificate of Conformance (which is shipped with every device) and must be lower
than 0.02mGy/hr in order for the device to successfully pass product release testing.
Primary Protective
Shielding
X-ray Source
Focal Spot
Focal Beam lim-
iting Devices
Backscatter
Radiation
Shielding
Test points for product release testing
A, B, C, D axis
G, H, I axis
H
I
G
F
E
BA
D
C
1110
Scatter
As discussed in Section 2.1 Radiation Safety, the transparent shield on the KaVo NOMAD
PRO 2 collimator, when properly oriented, acts as a barrier against backscatter radiation,
making it safe for the operator to stay in the room.
The significant zone of occupancy for operators has been further verified by internal
testing. A KaVo NOMAD PRO 2 device was remotely fired into a water phantom
repeatedly, with an ion chamber recording radiation readings at 336 points in the room,
first to establish the vertical significant zone of occupancy and then to establish the
horizontal significant zone of occupancy. Each exposure was taken at 1.00 seconds in
order to simulate “worse case scenario” results. The vertical significant zone of occupancy
measures 60 cm X 200 cm, while the horizontal significant zone of occupancy is 60 cm X
60 cm. A calibrated survey dosemeter can be used in order to confirm scatter radiation
data shown in the following diagrams.
For further information on these tests, please contact KaVo.
Vertical Plane,
Significant Zone of Occupancy:
60 cm x 200 cm
Horizontal Plane,
Significant Zone of Occupancy:
60 cm x 60 cm
2.3 Usage and Duty Cycle
As a safety feature, the KaVo NOMAD PRO 2 will not emit X-rays with insufficient voltage
(low battery).
The KaVo NOMAD PRO 2 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. This duty cycle is
programmed into your KaVo NOMAD PRO 2.
Do not operate the KaVo NOMAD PRO 2, the handset, charging cradle, or AC
power supply if equipment was subjected to moisture (wetting, immersing, or
soaking). Return to KaVo or authorized service center for service.
• Do not open the housings. Doing so will void the warranty. There are no user
serviceable parts inside the KaVo NOMAD PRO 2, handset, charging cradle, or AC
power supply.
• The KaVo NOMAD PRO 2 should not be used in environments where flammable
cleaning agents are present.
• Locate the charging cradle away from the normal patient environment.
• Connect only items that are specified as part of the system or that are specified as
being compatible with the system.
2.4 Cleaning
Use a non-acetone based disinfectant wipe or a cloth to wipe the exterior surfaces
of the KaVo NOMAD PRO 2 and charger. Do not use cleaners intended for hard surfaces,
since certain chemical combinations may deteriorate the KaVo NOMAD PRO 2 plastic
prematurely.
Leave the handset connected to the KaVo NOMAD PRO 2 and wipe down all surfaces
of the device.
Unplug the charging cradle before cleaning.
NOTE: The KaVo NOMAD PRO 2, the handsets, the charging cradle, and the AC power
supply are not designed to be subjected to any kind of sterilization procedure.
Alignment Bars
It is recommended to follow facility established cleaning and disinfection procedures. If the
infection control guidelines in your country permit, the alignment bars can be disinfected
using appropriate cleaning agents. Refer to cleaning agent manufacturer instructions.
Do not spray disinfectant or cleaners directly on the KaVo NOMAD PRO 2, handsets,
charging cradle, or AC power supply. The connecting areas are open to ingress and
damage to your device may result.
1312
2.5 Security, Storage, and Transportation
• Do not store the KaVo NOMAD PRO 2, handsets, charging cradle, or AC power supply
in extreme conditions: below -4°F (–20°C) or above 122°F (+50°C), or beyond 90%
relative humidity (non-condensing). The optimal storage location is cool, dry, and away
from direct sunlight.
• KaVo recommends that the KaVo NOMAD PRO 2 (like all electronic equipment) be
allowed to acclimate before use when switching between temperature extremes (i.e.,
cold storage area to a warm use area or hot storage area to a cool use area).
• When finished for the day with the KaVo NOMAD PRO 2, detach the handset.
• The X-ray Lock and Unlock (Section 4.2) serves as the device security key to prevent
unauthorized use. In addition, it is recommended that the device be locked away when
not in use. For a further level of security, securely store handsets in a separate location.
• Take steps to ensure the KaVo NOMAD PRO 2 will not be knocked to the ground when
not in use by laying it on its side. Power will automatically shut off after a period of
inactivity (approximately three minutes).
• Some battery charge may be lost during extended inactivity (leading to fewer
exposures between handset charging cycles).
• The KaVo NOMAD PRO 2 should not be operated if it has been dropped or if
performance degrades; it should be returned to KaVo or an authorized service
center for an evaluation.
• When finished for the day with the KaVo NOMAD PRO 2, detach the handset.
• Handset should be at least 2/3 charged for long term storage. Do not store
haphazardly or in contact with metal objects. Store in a cool, dry place.
2.6 Product Symbols
Caution: U.S. Federal law restricts this device to sale by or on the order of a
physician or other licensed practitioner.
Type BF Equipment (providing a degree of protection against electric shock,
pertaining particularly to allowable leakage currents) complying with IEC 60601-1
Warning of ionizing radiation
CAUTION: X-RAYS - ATTENTION: RAYONS X
The positive and negative connections (the polarity) of a d.c. power supply.
Filtration value
X-ray source assembly
Focal Spot
Marking indicating that product is compliant with certain North American safety
standards
Power Switch
The product meets all the legal requirements for CE markings and can be sold
throughout the European Economic Area
General warning
Caution
Recycling instructions
Used Electrical and electronic products should not be mixed with general
household waste
Manufacturer
1514
Date of manufacture
Model/Catalog number
Serial number
Follow Operating Instructions for Use
The name and address of the Authorized Representative in the European
Community
Dangerous Voltage: Electrical Shock Hazard
The maximum and minimum temperature limits at which the item shall be stored
transported or used
Kept away from rain and in dry conditions
To indicate that the content of the transport package are fragile and the package
shall be handled with care
Audible signal, indicating audible cues emitted by device during operation
The acceptable upper and lower limits of relative humidity for transport and
storage
REF
SN
EC REP
2.7 Location of Device Labels
The KaVo Handheld X-ray System and Charger have identification labels that specify the
model number and applicable product approval listings.
Conforms to AAMIES60601-1,IEC STDS. 606011-3, 60601-1-6, 60601-2-65, 62366. Certified
to CSA STD. C22.2 No. 60606-1. Complies with
FDA radiation performance standards 21 CFR,
subchapter J.
Location: Top surface of the NOMAD handheld
device.
Use only with 1.013.2001, 1.013.2002 or
1.013.4299 charging cradle
Contains Li-ion Battery
Location: Top of device handset
(visible when detached from device).
Max Input
Max Output
Use only with 1.013.1887, 1.013.1901 or
1.013.4192 handset
Use only with 0.850.0165 AC/DC adapter
Location: Bottom surface of Charging Cradle
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