Nomad Pro Manual
Nomad Pro Manual
Nomad Pro Manual
Operator Manual
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:
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.
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.
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.
• 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.
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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 These two items provide operator protection and should be inspected for
Backscatter Shield 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
• 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 Receiving Adequate Power
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.
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.
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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.
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.
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• 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).
• 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.
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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:
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.
A, B, C, D axis
E
G
A B
G, H, I axis
C D F I
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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.
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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.
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
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.
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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.
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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.
The positive and negative connections (the polarity) of a d.c. power supply.
Filtration value
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
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Date of manufacture
SN Serial number
The maximum and minimum temperature limits at which the item shall be stored
transported or used
To indicate that the content of the transport package are fragile and the package
shall be handled with care
The acceptable upper and lower limits of relative humidity for transport and
storage
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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.
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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3.0 Setup and Power Check
3.1 The Backscatter Shield
In addition to the radiation shielded cone, the backscatter shield provides additional
protection to the operator and can be adjusted to permit exposures made at various
angles.
To keep the shield securely on the cone, a cap is permanently attached at the
outer cone end. Do not attempt to remove this cap or to remove the backscatter shield.
Attempting to do so will result in damage to your device.
There are electric voltages present at the handset terminals. Protect the handset from
damage; do not probe with fingers or conductive objects.
The display panel will activate with a battery power level icon in the upper right
corner. Five bars is an indication of a fully charged handset.
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If the battery charge is too low, the KaVo NOMAD PRO 2 will not emit an X-ray and
the Recharge Handset alarm will display.
When a battery is depleted to the single bar level , it is recommended the handset
be recharged. Remove the handset from the charging cradle once it is fully charged.
Replace a low charge handset with the secondary handset (which should be charged
in advance). It is recommended that you keep one handset fully charged at all times to
ensure continuous operation.
The KaVo NOMAD PRO 2 has an X-ray disable feature that allows the X-rays to be
disabled for training purposes. Test firing this X-ray unit may otherwise be dangerous to
the testing technician or bystanders. See Section 4.2 for more information.
• Power On/Off: Attach a fully charged handset to the KaVo NOMAD PRO 2 device.
Press the Power button and verify that the device correctly powers on and off.
• Increase/Decrease Exposure Time: With the device on, select the patient size,
the image receptor type, and the tooth type. The exposure time corresponding to
the selections will display on-screen. Press the Increase and the Decrease
buttons, and verify that the exposure time changes appropriately. When the
Increase or Decrease buttons are pressed and held, the rate at which the
displayed time setting changes on screen accelerates.
• Triggering: With the device on and an exposure time selected, press and release
the trigger once. This will ready the device, and the display will indicate the Ready
state. To end the Ready state, press any button on the user interface panel or wait
approximately 15 seconds for the timeout.
• Automatic Shut-down: With the device on, allow approximately three minutes of
inactivity to pass for the system to automatically shut down.
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.
(See Section 6.1 Alarms and Alerts for more information.)
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4.0 Operation
4.1 Powering Up
NOTE: The manufacturer’s recommendation is for the operator to wear nitrile or other
gloves during basic operation of the KaVo NOMAD PRO 2.
Press and release the Power button to turn on KaVo NOMAD PRO 2. An audible
double tone and an active display panel indicate the device has power.
Technique factors are redisplayed according to what was displayed when the device was
turned off, along with the last saved time setting.
NOTE: If the Select button is held down for longer than 3 seconds before the Patient
button is pressed, the Menu mode will activate; if the Select button is pressed and
released before the Patient button is pressed, the Save menu is displayed.
To change exposure settings press each of the buttons to toggle through the choices:
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Examples from factory default settings:
When necessary, use the Increase or Decrease buttons to adjust the time in 0.01 second
increments. Adjusted exposure settings may be saved, replacing factory settings (see
Section 4.9 Technique Factors Settings and Adjustments).
Press and release the trigger once to ready the device. The device will briefly display an
Enabling X-rays message before indicating Ready.
NOTE: As a safety precaution, if the trigger is held longer than one second or pulled a
second time while still in the Enabling X-rays state, the device will not transition to the
Ready state. (This is to prevent an accidental activation of the device by unintended
triggering.)
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4.5 Initiating and Completing an X-ray Exposure
To begin the exposure, press and
hold the trigger. The Ready alert is
replaced with the X-rays On alert,
the green LED is replaced with a
yellow LED, and there is an alert tone
for the duration of the exposure.
The KaVo NOMAD PRO 2 also automatically shuts off after approximately three minutes of
inactivity.
The KaVo NOMAD PRO 2 display darkens, accompanied by a tone to indicate shut-down.
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4.7 Exposure Techniques
As an intra-oral dental X-ray system, the KaVo
NOMAD PRO 2 can be easily positioned. This high
degree of flexibility makes it easy to take exposures
while the patient is reclined, lying completely on their
back, or sitting upright. Ensure the patient is protected
by using an apron.
NOTE: Both digital imaging sensors and film and phosphor plate speeds can vary
somewhat in their characteristics and could require different exposure settings to meet
density preference. (See Section 4.10 Settings Menu for more information.)
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4.8 Ensuring Image Quality
The following KaVo NOMAD PRO 2 features contribute to high image quality:
• DC voltage X-ray generation is efficient in delivering energy at the level optimized for
diagnostics, with shorter exposure times required.
• The smaller the focal spot, the better the resolution. The KaVo NOMAD PRO 2 has a
small 0.4mm focal spot.
• Absorption of scatter by the KaVo NOMAD PRO 2 backscatter shield reduces incidence
of noise for the image receptor, which tends to increase image contrast.
Image degradation or blurriness does not result due to motion of the handheld X-ray
source.
To ensure image quality, use correct time settings. The KaVo NOMAD PRO 2 comes with
pre-sets to give you a starting point. However, these time settings can be adjusted to
achieve the desired image quality and then saved for future use. See Section 4.10 Settings
Menu for further help.
The KaVo NOMAD PRO 2 works with the fastest sensor technologies in the market to
assure that exposure times are as short as possible, also limiting any effects of motion.
Make sure you are as close to the patient’s cheek as possible without touching. If your
sensor holder prevents you from getting close enough, you may want to use the Short
Alignment Bars, enabling the KaVo NOMAD PRO 2 to be placed directly against the
positioning ring.
Always double-check for the Incomplete Exposure alarm on the KaVo NOMAD PRO
2 display. The Incomplete Exposure alarm indicates that the trigger was released
prematurely, resulting in an incomplete exposure. To achieve complete exposures, do the
following: quickly press and release the trigger to enable the X-ray and wait for the device
to shift to the Ready state; press and hold the trigger until the audible tones and the
display indicate the X-ray Complete alert.
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4.9 Technique Factors Settings and Adjustments
The factory settings in this chart are intended as a reference starting point only and are
based upon average preferences and use with the cone perpendicular to the image
receptor. Individual results may vary based upon a number of factors including image
density preferences, the various imaging sensors or available film speeds and brands,
patient size, practitioner techniques, and preferences.
Pediatric Considerations
Use of equipment and exposure settings designed for an average-sized adult can result in
excessive radiation exposure for a smaller patient, especially pediatric. 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. Please use caution when configuring the KaVo NOMAD PRO 2 by
considering the patient’s age, size, body habitus, and clinical indication when verifying
exposure time settings.
The following links to US FDA and Image Gently websites are useful resources for pediatric
imaging guidelines and information:
https://www.fda.gov/Radiation-EmittingProducts/RadiationEmittingProductsandProcedures/
MedicalImaging/default.htm
http://www.imagegently.org/Procedures/Dental#35771809-guidelines-and-resources
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Technique Factor time settings can be adjusted by the operator. This is done from the
main display screen by following these steps:
Press the Increase or Decrease buttons until the desired time setting is
selected.
NOTE: When the Increase or Decrease buttons are pressed and held, the rate at
which the displayed time setting changes on screen accelerates.
Press and release the Select button to activate the Save Menu.
Once saved, this change will be maintained in memory until overwritten or until the
factory defaults are restored through the Reset Defaults menu item.
Within the menu items there are options (such as Yes and No) which are selected using
either the Increase or Decrease buttons. Once a selection is made, pressing the
Select button confirms the choice.
To exit the Main Menu, highlight Exit at the bottom of the list and then press the Select
button, or power the device off and then on.
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Menu Item Function
The device will display two counters. One is the Overall History
Counter, which displays the total lifetime X-ray shots for the
device. The other, Trip Counter, can at any time be reset
to zero by the operator.
When Reset is selected and the Select button is pressed, the
user will be prompted with the message Reset Trip Counter?
When Yes is selected and the Select button is pressed, the Trip
X-ray Counter Counter is reset to zero and the device is returned to the counter
display.
When No is selected and the Select button is pressed, the
device is returned to the counter display with no change.
When Back is selected and the Select button is pressed, the
device returns to the Main Menu.
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5.0 Handset Replacement and Care
• Handsets must be charged before initial use. Alternate handsets each week to
maximize service life. Handset should be at least 2/3 charged for long term storage.
• After daily use, it is recommended to disconnect the Handset from the device housing
for overnight storage.
• Do not spray disinfectant or cleansers directly on to the handsets.
• Remove the handsets from the charging cradle once they are fully charged.
• Battery life is expected to be at least 2 years with proper care and maintenance.
• Batteries and Handsets may only be replaced with KaVo NOMAD PRO 2 Handsets.
• Battery charge will diminish during extended inactivity. Fully recharge handsets every
three months during inactivity. Never place a low charged battery into long-term
storage.
• To quickly check the charger level of a handset when it is not attached to the tube
head or charger, pull the trigger and watch the dark red window. A blinking light will
indicate the charger level from 1 (low) to 5 (high).
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• Do not attempt to charge a handset with damaged batteries. Damage can occur
if handset experiences liquid ingress, if it has been dropped or punctured, or
exposed to heat or fire. Replace handset immediately if there are any signs of
deterioration or if batteries do not retain a charge during normal operation.
• Risk of fire or explosion exists if batteries inside the handset are replaced by
unauthorized service personnel; do not use batteries from other sources.
• Properly dispose of spent or damaged handsets; return to KaVo or an authorized
distributor for replacement and recycling. Do not place in municipal waste stream.
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6.0 KaVo NOMAD PRO 2 Care and Upkeep
6.1 Alarms and Alerts
The visual and audible alarms signal a programmed action designed to prevent harm to
operators, patients, and/or the KaVo NOMAD PRO 2. The visual/audible alerts confirm
normal conditions or draw the operator’s attention to a required action.
NOTE: All audible signals except X-ray termination and completion may be turned down
or off in the Audible Sounds menu. See Section 4.10 Settings Menu.
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Alerts & Alarms: Visual and Audible Indicators Function/Resolution
Visual Audible
X-ray
Exposure
Alert
X-ray
Complete
Alert
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Alerts & Alarms: Visual and Audible Indicators Function/Resolution
Visual Audible
The KaVo NOMAD PRO 2 should not be operated if it has been dropped or if
performance degrades; it should be returned to KaVo for an evaluation.
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6.2 Troubleshooting
If you encounter results and/or errors in the operation of the KaVo NOMAD PRO
2 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 KaVo: [email protected]
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Device Symptom Potential Problem Corrective Action
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Device Symptom Potential Problem Corrective Action
The handset, in general, is
not communicating with Ensure handset is securely attached.
the device.
Replace with a newly charged handset in
order to continue. Use the charging cradle to
6.2.12 Handset The batteries are impaired determine the handset status. If the charging
Failure alarm or at the end of their life bars illuminate solid red or if no illumination
displayed on screen. cycle. occurs, the handset will require authorized
service; see Section 7.0 Maintenance and
Repair.
A different problem exists KaVo NOMAD PRO 2 will require authorized
if all handsets appear service; see Section 7.0 Maintenance and
fully charged. Repair.
If the green power
indicator is illuminated Ensure that compatible components are
but the handset fails to being used by checking the labels of both the
charge, there may be an handset and charger and verifying that the
issue with compatibility of correct part numbers are being used.
components.
Plug in the charger. Place the handset on the
6.2.13 Handset
charger. Leaving the handset on the charger,
does not completely
unplug the charger by unplugging the power
charge after 5 hours. If the green power
supply from either the cradle or the wall. Plug
indicator is illuminated but in the charger to reset the handset and begin
the correct components fail charging. Charging a handset from the sleep
to charge, the handset may mode may take slightly longer than normal.
be in sleep mode.
If the process described above fails to recover
the handset, authorized service is required; see
Section 7.0 Maintenance and Repair.
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7.0 Maintenance and Repair
Incorrect operation or failure to maintain the device in accordance with the maintenance
schedule relieves the manufacturer or his agent from all the responsibilities for subsequent
non-compliance, damage, injury, defect and/or other malfunction. It is strongly
recommended that only authorized Service Representatives, trained specifically on the
KaVo NOMAD PRO 2 device, maintain and service the device.
Modifications and additions to the device (including replacement of power cords and
exposure switches) must be carried out only by personnel or third parties that are expressly
authorized by KaVo, and must comply with the applicable legal requirements as well as
with the generally accepted technical regulations.
On-going Maintenance: Observe the following steps for on-going maintenance of the
KaVo NOMAD PRO 2.
1. The KaVo NOMAD PRO 2 may be sent to KaVo for a maintenance and inspections as
required by local regulatory authority.
2. Review Section 1.1 Indications for Use and product labeling periodically in order to
verify understanding of indications for use for the KaVo NOMAD PRO 2.
3. A routine wipe-down of the KaVo NOMAD PRO 2 with a disinfectant cloth or wipe-
down between patients is recommended, along with a quarterly visual inspection for
damage. Make sure the power is off while cleaning. It is recommended for the handset
to be attached during cleaning of the device. Use a non-acetone based disinfectant
wipe or a cloth to wipe the exterior surfaces of the device and charging cradle. Do
not use cleaners intended for hard surfaces, since certain chemical combinations may
deteriorate the KaVo NOMAD PRO 2 plastic prematurely. Also do not use cleaners that
leave any sort of residue or sticky build-up on the device surface. Such cleaners can
eventually interfere with properly connecting and disconnecting the handset.
4. See also Section 5.0 Handset Replacement and Care for more information related to
Handset maintenance.
5. Periodically assess operator familiarity with the KaVo NOMAD PRO 2 in order
to determine whether refresher training/certification (per local, national, and
jurisdictional requirements) is needed.
6. Periodically review Section 4.9 Technique Factors Settings and Adjustments for
comprehension and to assess whether or not chart information is being incorporated
into daily use.
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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: Observe the following steps for annual maintenance of the KaVo
NOMAD PRO 2.
1. Verify that the Power button is working properly. When the device is powered on, the
display should illuminate and an indicator alarm should sound.
2. Verify that the device is in lock mode when the Patient and Select buttons are
pressed simultaneously. Repeat the process to unlock the device. Verify that the device
is unlocked.
3. Verify that, when left on for a period of approximately three minutes without pressing
any buttons, the device automatically shuts off.
4. With the device powered on and unlocked, verify that a time selection value displays
on the user interface panel. Also check the function of the Increase and
Decrease buttons. Pressing the buttons should cause the time setting to adjust
accordingly.
5. Verify that the trigger moves freely in and out when depressed and released.
6. Verify that a single pull and release of the trigger enables the X-rays and the device
moves into the Ready state.
7. Verify that the backscatter shield is firmly attached to the collimator cone and that it is
not cracked or broken.
8. Select an exposure of 1.00 second using the time exposure buttons. Initiate an
exposure, but release the exposure switch after a brief period of time before the timer
terminates the exposure. Verify that the exposure terminates immediately upon release
of the trigger.
9. While taking the exposure, verify that the X-Rays On LED illuminates and the audible
signal is heard.
10. Ensure that the operator of the system has received a copy of the operator manual.
• The KaVo NOMAD PRO 2 should not be operated if it has been dropped, if housing
is broken, if performance degrades, or if the backscatter shield has been broken or
compromised in any way; it should be returned to KaVo for an evaluation.
• For long-term storage, it is recommended to charge batteries at least 2/3 every 3
months.
The KaVo NOMAD PRO 2, the handsets, and the charging cradle are NOT designed
to be user-serviceable. There are dangerous voltages inside. Do not open the device,
handset, or charger housing doing so will void the warranty.
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7.2 Calibration Checks
The KaVo NOMAD PRO 2 is factory calibrated and tested prior to release (see your
Certificate of Conformance) and there are no adjustment options.
Prior to checking the PRO 2 calibration performance, please review the information
provided below.
The following is a detail of the testing equipment, used at the factory, to check
conformance of the KaVo NOMAD PRO 2. Using other test instruments may yield differing
results. Please contact Customer Care for additional testing guidelines.
Keep the Box: 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 a protective lead apron and thyroid collar, are observed.
This X-ray unit may be dangerous to the testing technician and any bystanders unless safe
test exposure factors, such as placing the test detector in a lead lined box or using a
protective lead apron and thyroid collar, are observed.
Enable the KaVo NOMAD PRO 2 and, with the cone perpendicular to the test detector, make
exposures into the test detector and capture the resulting data.
Compare the results with the factory release parameters (indicated in the chart below). For
results outside these parameters, discontinue use and contact your dealer/distributor or
KaVo.
A duty cycle of 1:60 is required after each X-ray discharge to prevent over-heating
damage to the X-ray tube.
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7.3 Maintenance Log Sheets
Inspection at KaVo
4. Time Selection Buttons
5. Trigger
6. Enable/Ready State
7. Backscatter Shield
8. Exposure Termination
9. X-Rays On LED and Audible Signal
10. Operator Manual
11. Calibration Checks (Optional)
Inspection at KaVo
4. Time Selection Buttons
5. Trigger
6. Enable/Ready State
7. Backscatter Shield
8. Exposure Termination
9. X-Rays On LED and Audible Signal
10. Operator Manual
11. Calibration Checks (Optional)
*It is recommended to replace handsets after years 2 and 4. Contact KaVo for more information on covering
battery replacement through the KaVo NOMAD PRO 2 Care Plan.
7.4 Repair
There are no parts designated as repairable in the field by the owner/user of the device,
including fuses. Contact your KaVo Service Representative if repairs are needed.
Only KaVo supplied components may be used. Substituting KaVo parts may cause
incorrect operation or failure to the device.
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The following are user replaceable components:
• Handsets (1.013.1887)
• Alignment Bars:
Universal (1.011.83669), Endodontic (1.011.3671), Bitewing (1.011.3672)
Damaged or faulty KaVo NOMAD PRO 2 materials and components must be properly
disposed of according to local requirements, or returned to an authorized distributor or
KaVo, Inc. Please protect the environment, and do not improperly dispose of any part of the
KaVo NOMAD PRO 2 system, the handsets, the charging cradle, or the AC power supply. At
end of life, return these items to KaVo for replacement, and proper disposal or recycling.
• Do not dispose of any parts of this product with industrial or domestic waste.
Incorrect disposal of any of these materials may lead to serious environmental
pollution.
• Properly dispose of spent or damaged handsets; return to KaVo or an authorized
distributor for replacement and recycling. Do not place in municipal waste stream.
If product return is required, contact KaVo for a Return Material Authorization (RMA)
number and shipping instructions to return the product to an KaVo authorized service
center. You will be required to provide the serial number from the label affixed on the
underside of the KaVo NOMAD PRO 2.
Be sure to include the RMA number on the package you are returning. Products without an
RMA number cannot be serviced or given credit consideration.
KaVo will not assume responsibility for shipping damages; however, it will help you file a
claim with the freight carrier.
To avoid any potential hazard or danger to Operators and Patients, contact your
authorized Service Representative immediately if you experience any unusual operation,
non-recoverable faults, or equipment malfunctions or failures.
Do not operate the device with any covers open or removed. Operating the device with
open or removed covers could expose mechanical operating systems that could cause
serious or fatal personal injury to you or the Patient. Only qualified and authorized
service personnel should remove covers from the device.
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8.0 Technical Description
8.1 Basic Technical Specifications
Maximum deviation from fixed factors: ±5% (unless otherwise noted)
Total weight: 2.7kg
Environmental
Operation
Temperature 50°F (+10°C) to 104°F (+40°C)
Relative humidity 30% to 80%, non-condensing
Storage and transportation
Temperature -4°F (-20°C) to 122°F (+50°C)
Relative humidity <90%, non-condensing
Do not use the KaVo NOMAD PRO 2 outside of the temperature and relative humidity
ranges specified.
Electrical
Rechargeable lithium batteries 21.6V nominal; 24.6V maximum, 1.7A/hr
Battery current at 2.5mA, 60kVp output 12.5A
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X-ray Controls and Generator
Leakage technique factors 60kV, 2.5mA, 1.00 sec.
Maximum air kerma at handgrips and <0.08mGy in 1 hour
control panel
Collimator Cone
Minimum source to skin distance 21cm (from focal spot to cone tip)
Nominal dose output at cone tip (20cm) 3.41mGy/sec.
X-ray field size and configuration 6cm diameter circle
Overall deviation of the air kerma from the values shown does not exceed 40%. The exit
field size at the end of the collimator cone (20 cm from the focal spot) is 6 cm. Therefore,
2
6 cm
DAP = mGy × 𝜋𝜋 × � �
2
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8.2 X-ray Tube Specifications and Characteristics
The KL 11-0.4-70 is designed for intra-oral dental imaging by an X-ray unit and
is available for nominal tube voltage with self-rectified or constant potential circuit –
manufactured by Kailong.
Nominal tube voltage 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/75kV
X-ray source assembly maximum heat content 6500J
X-ray source assembly PS454
CENTRAL X-RAY
F: FILAMENT
C: CATHODE
OUTLINE DRAWING
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X-ray Source Focal Spot X-ray Source Focal Spot
X-ray
Beam
Optional
Rectangular Collimator
Exit Field Size
3 cm x 4 cm
NOTE: The optional Rectangular Collimator Cone Adapter dimensions are contained entirely
within the 6 cm circular exit field diameter. This collimator can rotate freely, 360 degrees.
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Cathode Emission/Filament Characteristics Chart
Rating Chart
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8.3 Manufacturer’s Declaration
The KaVo NOMAD PRO 2 Dental X-ray System has been tested and found to comply with
the limits of electromagnetic compatibility standards for medical devices, which provide
reasonable protection against harmful interference in a typical medical/dental setting.
The KaVo NOMAD PRO 2 may generate and radiate radio frequency energy that causes
interference to other devices in the vicinity, if not used in accordance with the instructions
(though there is no guarantee that interference will not occur in a particular instance).
If interference occurs, the user is encouraged to try the following corrective measures:
reorient or relocate the receiving device; increase the separation between the equipment;
consult the device manufacturer or field service technician for help.
The KaVo NOMAD PRO 2 is intended for use in the electromagnetic environment as
specified. The following tables describe the tests performed and the status of the testing.
The KaVo NOMAD PRO 2 uses RF energy only for its internal function. Its RF emissions are
very low and are not likely to cause any interference in nearby electronic equipment.
The test results show that the KaVo NOMAD PRO 2 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.
The KaVo NOMAD PRO 2, classified as Medical Electrical Equipment, needs special
precautions regarding EMC and must be installed and put into service according to the
EMC information provided in the accompanying product documentation. Portable and
Mobile RF Communications Equipment can affect Medical Electrical Equipment.
The KaVo NOMAD PRO 2 is suitable for use in hospitals except for near active HF surgical
equipment and the RF shielded room of an ME system for magnetic resonance imaging,
where the intensity of EM disturbance is high.
The KaVo NOMAD PRO 2 device should not be used adjacent to or stacked with
other equipment. If adjacent or stacked use is necessary, the device should be
observed to verify normal operation in the configuration in which it will be used.
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Guidance and Manufacturer’s Declaration – Electromagnetic Emissions
The KaVo NOMAD PRO 2 Intraoral X-ray System is intended for use in the electromagnetic environment
specified below. The customer or user of the KaVo NOMAD PRO 2 Intraoral X-ray System should ensure that
it is used in such an environment.
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Immunity Test Summary
The KaVo NOMAD PRO 2 Intraoral X-ray System is intended for use in the electromagnetic environment
specified below. The customer or user of the KaVo NOMAD PRO 2 Intraoral X-ray System should ensure that
it is used in such an environment.
Electrostatic +/-8 kV contact +/-2, 4, 6 & 8kV Floors should be wood, concrete or
Discharge (ESD) contact
ceramic tile. If floors are synthetic, the
+/-2, 4, 8, & 15 kV air r/h should be at least 30%
IEC 61000-4-2 +/-15kV air
+/-2 kV for +/-0.5, 1 & 2 kV for
power
Electrical fast power supply lines
supply lines Mains power quality should be that
Transient/burst of a typical commercial or hospital
+/-1 kV for input/ environment.
IEC 61000-4-4
output lines +/-0.5 & 1 kV for
input/output lines
+/-1 kV +/-0.5 & 1 kV
differential mode
Surge differential mode Mains power quality should be that
of a typical commercial or hospital
IEC 61000-4-5 +/-0.5, 1 & 2 kV environment.
+/-2 kV common
mode
100 % Dip; for 0,5 100 % Dip for 0,5
cycles cycles
Voltage dips, At 0°, 45°, 90°, 135°, At 0°, 45°, 90°, 135°,
short 180°, 225°, 270° and 180°, 225°, 270° and Mains power quality should be that
315° 315° of a typical commercial or hospital
interruptions and
environment. If the user of the KaVo
voltage variations 60% Dip for 60% Dip for NOMAD PRO 2 Intraoral X-ray
on power supply System requires continued operation
1 Cycle 1 Cycle during power mains interruptions,
input lines it is recommended that the KaVo
30% Dip for 30% Dip for NOMAD PRO 2 Intraoral X-ray System
be powered from an uninterruptible
IEC 61000-4-11 25 Cycles 25 Cycles
power supply or battery.
5 Seconds 5 Seconds
Power frequency
(50/60 Hz) Power frequency magnetic fields should
magnetic field 30A/m 3 & 30A/m be that of a typical commercial or
hospital environment.
IEC 61000-4-8
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Guidance and Manufacturer’s Declaration – Electromagnetic Emissions
The KaVo NOMAD PRO 2 Intraoral X-ray System is intended for use in the electromagnetic environment
specified below. The customer or user of the KaVo NOMAD PRO 2 Intraoral X-ray System should ensure that
it is used in such an environment.
D=(7/E1)(Sqrt P)
800 MHz to 2.5 GHz
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Guidance and Manufacturer’s Declaration – Electromagnetic Emissions
The KaVo NOMAD PRO 2 Intraoral X-ray System is intended for use in the electromagnetic environment
specified below. The customer or user of the KaVo NOMAD PRO 2 Intraoral X-ray System should ensure that
it is used in such an environment.
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
• Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV
broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be considered.
If the measured field strength in the location in which the Model 005 is used exceeds the
applicable RF compliance level above, the Model 005 should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such
as re-orienting or relocating the Model 005.
• Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 1 V/m.
• The ISM (industrial, scientific and medical) bands between 0.15 MHz and 80 MHz are 6.765
MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz
to 40.70 MHz. The amateur radio bands between 0.15 MHz and 80 MHz are 1.8 MHz to 2.0
MHz, 3.5 MHz to 4.0 MHz, 5.3 MHz to 5.4 MHz, 7 MHz to 7.3 MHz, 10.1 MHz to 10.15 MHz,
14 MHz to 14.2 MHz, 18.07 MHz to 18.17 MHz, 21.0 MHz to 21.4 MHz, 24.89 MHz to 24.99
MHz, 28.0 MHz to 29.7 MHz and 50.0 MHz to 54.0 MHz.
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Recommended Separation Distances Between
Portable and Mobile RF Communications Equipment and the KaVo NOMAD PRO 2 device
The KaVo NOMAD PRO 2 Intraoral X-ray System is intended for use in the electromagnetic environment
in which radiated disturbances are controlled. The customer or user of the KaVo NOMAD PRO 2 Intraoral
X-ray System can help prevent electromagnetic interference by maintaining a minimum distance between
portable and mobile RF Communications Equipment and the KaVo NOMAD PRO 2 Intraoral X-ray Systems
recommended below, according to the maximum output power of the communications equipment.
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8.4 Cables
The following table lists cables used with the device. No support equipment is used with
the device.
Always use supplied cables. The use of an accessory, transducer, or cable with the
system other than those specified may result in increased emissions or decreased
immunity of the system.
Cables
LIMITED WARRANTY
COVERAGE. KaVo 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. KaVo also warrants
any accessories purchased from an authorized reseller. KaVo also warrants any defects in material or
workmanship for the period of one (1) year from the date of purchase.
The liability of KaVo is limited to repair or replacement of any parts that KaVo or its authorized resellers
determine to be defective. Contact KaVo for a Return Material Authorization (RMA) number and shipping
instructions. Parts proving defective shall be repaired or replaced free of charge (labor and shipping
included) if defective equipment is returned freight collect to KaVo (North Carolina, 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, and/or damaged as a result of any carelessness or accidents. This warranty
does not apply to equipment purchased, leased, or otherwise obtained from including, but not limited to,
persons, resellers, and Internet resellers that are not KaVo authorized resellers. This warranty does not
cover ordinary wear and tear or maintenance. To verify the authorization status of a KaVo reseller, please
contact KaVo at 1-866-340-5522.
LIMITATIONS OF LIABILITY. KaVo makes no other warranty, either expressed or implied, with respect to
any equipment purchased from KaVo or an authorized reseller, including without limitation any implied
warranties of merchantability or fitness for a particular purpose, whether or not KaVo may have been
informed of the actual uses to which any of such equipment may be put. KaVo 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 KaVo 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.
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0413
DEVICE HAS BEEN CERTIFIED TO MEET THE REQUIREMENTS OF COUNCIL DIRECTIVE 93/42/EEC CONCERNING MEDICAL DEVICES.
EC REP
©
2018 Aribex 1.013.3038 EN Rev A 2018 February 1