Carestream DENTAL Nanoray CS 2400P User manual

Battery-Free
Portable Dental X-ray
USER MANUAL Doc. UM-02FC-01
(Rev.5, 2021.01.29)

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Notice
DO NOT OPERATE THIS DEVICE UNTIL YOU HAVE READ THIS MANUAL AND
SELF-TRAINED WITH THE CS 2400P SAFETY VIDEO.
The CS 2400P /NP-350E, is a Battery-Free Portable Dental X-ray.(Non-Continuous operation)
This manual contains descriptions, operational instructions, imaging procedures for the CS 2400P /
NP-350E dental X-ray. It is recommended that you thoroughly familiarize yourself with this manual in
order to make the most effective use of this equipment.
Observe all cautions, safety messages and warnings that appear in this manual.
Keep this manual with the equipment at all times, and review the operation procedures and safety
instructions if needed.
The illustrations/photos of the equipment in this manual are only for illustration purposes. Actual
equipment may differ.
The safety and operating instructions should be retained for future reference.
All instructions should be followed.
This appliance should not be used near water
This appliance should be situated away from heat sources such as radiators, heat registers, stoves,
or other appliances (including amplifiers) that produce heat.
This appliance should be connected to a power supply only of the type described in the operating
instructions or as marked on the appliance. If you are not sure of the type of power supply to your
home, consult your appliance dealer or local power company.
If the appliance is equipped with a polarized alternating-current line plug, this plug will fit into the
power outlet only one way.
U.S. Federal law restricts this device to sale by or on the order of a dentist or physician.
U.S. patents issued : 10,881,364 B2
DISCLAIMER:
The Carestream Dental and CS 2400P logos are trademarks of Carestream Dental LLC. Nanoray
and NP-350E are trademarks of Nanoray Co., Ltd. worldwide. All other brand and product names
are trademarks or registered trademarks of their respective companies.

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Table of Contents
Notice..............................................................................................................................................2
Table of Contents .............................................................................................................................3
1. General and RegulatoryInformation.................................................................................................4
1.1 Manufacturer's Liability ............................................................................................4
1.2 Owner and Operator's Obligations............................................................................4
1.3 Conventions Used in this Manual..............................................................................5
1.4 Marks and Symbols..................................................................................................6
1.5 Standards and Regulations ....................................................................................12
1.6 Recommendation for an efficient operation.............................................................12
2. Safety Instructions..........................................................................................................................13
2.1 General Safety Guidelines......................................................................................13
2.2 Warnings and Safety Instructions............................................................................14
2.3 Using Super Capacitor............................................................................................17
2.4 Contraindication......................................................................................................17
2.5 Radiation Safety .....................................................................................................18
3. System Overview ...........................................................................................................................20
3.1 Indications for Use .................................................................................................21
3.2 Principles of Operation...........................................................................................21
3.3 Intended User Profile..............................................................................................21
3.4 Patient population and name of disease..................................................................22
3.5 Components ...........................................................................................................22
3.6 Features .................................................................................................................22
3.7 General view of the equipment................................................................................23
4. Instructions for Use........................................................................................................................25
4.1 The frequently used functions.................................................................................25
4.2 Change exposure time by manipulating the wheel ..................................................26
4.3 Power ON/OFF.......................................................................................................26
4.4 Lock/Unlock the X-ray.............................................................................................26
4.5 Select teeth.............................................................................................................26
4.6 Select Adult or child................................................................................................26
4.7 Select film...............................................................................................................27
4.8 LCD(Liquid Crystal Display) panel...........................................................................27
4.9 Checking the remaining charge in Super Capacitor.................................................28
4.10 Charging the Super Capacitor & Lock display......................................................... 28
4.11 Interfaces between the software system and other systems....................................29
4.12 Main functional elements and functionality..............................................................29
4.13 Exposure times Auto-save mode / Reset exposure time .........................................31
4.14 Troubleshooting......................................................................................................32
4.15 Charging the Battery...............................................................................................32
4.16 Change the Cone circle to Rectangular cover.........................................................33
5. Maintenance ..................................................................................................................................34
5.1 Storage...................................................................................................................34
5.2 Cleaning .................................................................................................................34
5.3 Maintenance...........................................................................................................35
6. Disposing of the Unit ......................................................................................................................37
7. Product Specifications....................................................................................................................38
7.1 Mechanical Specifications......................................................................................38
7.2 Technical Specifications.........................................................................................39
7.3 Electrical Specifications .........................................................................................43
7.4 Environmental Specifications..................................................................................43
8. Appendix .............................................................................................................................................44
8.1 Tables of Exposure Times (Default) ........................................................................44
8.2 X-ray Dose Data.....................................................................................................45
8.3 Electromagnetic Compatibility (EMC) Information ...................................................50
8.4 Abbreviations..........................................................................................................54
8.5 X-ray for Pediatric patients......................................................................................55

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1.1 Manufacturer's Liability
The manufacturers and/or retailers of this equipment assume responsibility for
the safe and normal operation of this product only when:
Genuine NANORAY approved equipment and components have been used
at all times.
All maintenance and repairs have been performed by NANORAY authorized
agent.
The equipment has been used normally in accordance with the user's
manual.
The equipment damage or malfunction is not the result of an error on the
part of the owner or operator.
1.2 Owner and Operator's Obligations
The owner of this equipment shall perform constancy tests at regular
intervals in order to ensure patient and operator safety. These tests must
be performed in accordance with local X-ray safety regulations.
The owner of this equipment shall perform regular inspection and
maintenance of the mechanical and electrical components in this
equipment to ensure safe and consistent operation (IEC 60601-1).
The owner of this equipment shall ensure inspection and cleaning work is
performed in accordance with the maintenance schedule outlined in
Chapter 5 Maintenance.
1. General and Regulatory Information

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1.3 Conventions Used in this Manual
The following symbols are used throughout this manual. Make sure that you
fully understand each symbol and follow the instructions which accompany it.
To prevent personal injury and/or damage to the equipment, please observe all
warnings and safety information included in this document.
WARNING
Indicates that a specific hazard is known to exist
which through inappropriate conditions or actions
may cause:
Severe personal injury (to the operator and/or
patient)
Substantial property damage.
CAUTION
Indicates that a potential hazard may exist which
through inappropriate conditions or actions will or
can cause:
Minor injury
Property damage.
IMPORTANT
Indicates that a potential problem may exist which
through inappropriate conditions or actions can
cause:
Property damage.
NOTE
Indicates precautions or recommendations that
should be used in the operation of the system,
specifically:
Using this Manual
Notes to emphasize or clarify apoint.

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1.4 Marks and Symbols
1.4.1 The following table describes the purpose and location of safety symbols
and other important information provided on the equipment.
1) Device symbol
Mark/Symbol Description Location
Alternate current Battery Charger
Label
ISO 15223 Manufacturer Main Label
ISO 15223 Date of manufacture Main Label
ISO 15223 Serial number Main Label
ISO 15223 Catalogue number Main Label
IEC60417-5031 Direct current Main Label
ISO 7000 Small focal spot Main Label
ISO15223 Temperature limit Main Label
ISO15223 Humidity limitation Main Label
ISO 7010 High voltage hazard Main Label
ISO 7010 Radiation hazard Main Label
Generator Label
ISO15223 Caution Main Label
European Community Directive 2012/19/EU
Waste Electrical and Electronic Equipment
Directive. Main Label
IEC60601 Applied part : Type B Main Label

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ISO 7010 Refer to instruction manual/booklet. Main Label
ISO15223 Authorized representative in the
European Community Main Label
CSA mark of conformity showing compliance
with the applicable US and Canadian
electrical safety regulations. Main Label
2) Shipping Box symbol
Mark/Symbol Description Location
ISO15223 Keep dry Box Label
ISO7000 This side up Box Label
ISO7000 Do not use if package is damaged Box Label
ISO15223 Fragile, handle with care Box Label
ISO15223 Temperature limit Box Label
ISO15223 Humidity limitation Box Label
ISO15223 Atmospheric pressure limitation Box Label
ISO 780 Stacking limit by number Box Label

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1.4.2 Labels and label positions
Device labels (55x80mm): NR-F350 and CS 2400P

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Cradle Label (45 X 30mm)
External exposure switch Label (45 X 30mm)
(Optional – not delivered in the generator kit)

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Adaptor Label (38 X 90mm)
Warning Label (50 X 20mm)

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Caution Label (60 X 20mm)

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1.5 Standards and Regulations
Standards:
The CS 2400P is designed and manufactured to meet the following standards:
IEC/EN 60601-1, IEC/EN 60601-1-2, IEC/EN 60601-1-3, IEC/EN60601-2-65
IEC 60601-2-65:2012 Particular requirements for the basic safety and essential
performance of dental intra-oral X-ray equipment
ISO 13485
FDA Center for Devices & Radiological Health: This product is in conformity with
performance standards for diagnostic X-ray systems and their major components
under 21 CFR 1020.30 and performance standards for ionizing radiation emitting
products 21 CFR 1020.31
Classifications (IEC60601-1 6.1):
Protection against the ingress of water: Ordinary Equipment (IPX0)
Protection against electric shock: Class I equipment, Type B Applied Parts: Cone head
1.6 Recommendation for an efficient operation
1) Please try to keep in ‘Recharging’ after using as the below table.
No
Exposing Value(Sec.)
Exposing Times
1
0.06
Max. 16 times
2
0.10
Max. 12 times
3
0.16
Max. 10 times
4
0.19
Max. 8 times
5
0.24
Max. 6 times
6
0.29
Max. 5 times
7
0.50
Max. 2 times
8
1.00
Max. 1 times

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2.1 General Safety Guidelines
1) General Safety Guidelines
-This product requires a longer break time than the exposure time after an X-ray
exposure. The minimum duty cycle rating (the relationship between duration and
frequency of exposures) is 1:90.
Duration
0.06s
0.32s
0.56s
1s
Cycle
Every 5.4s
Every 28.8s
Every 50.4s
Every 90s
-This product is designed and manufactured in order to ensure the maximum safety.
Operation and Maintenance must be in accordance with the instructions contained in
this manual.
-This product must only be operated by legally qualified.(Dentist or Dental hygienist)
-Observe all the local fire regulations keep a fire extinguisher near the product at all
times.
-Maintenance and services for the product should be taken by qualified service
personnel according to procedures and preventive maintenance schedules.
-Always turn off the product before cleaning.
-The device uses beam limiting device(rectangular cover) for protection against stray
radiation
2) Limit product temperature
-In order to protect the over temperature of the product, exposure shall not be
conducted if the generator temperature is higher than the set value.
-Display shows the measured temperature. (Ex display: 45.0℃)
-Before the generator temperature goes down, the downtime of the product is required
for at least 1 hour.
3) For self-protection functions, cooling time of about 5 minutes is required if the downtime
is insufficient.
-The downtime required for the display is displayed, and it cannot be exposure. (Ex
display : "300s")
- Self-protection function: Function that prevents temporary use of the product to
compensate for insufficient cooling time.
2. Safety Instructions

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2.2 Warnings and Safety Instructions
-Exposing the product to water or moisture may cause an electrical shock or damage
the product. Keep it away from water and moisture.
-Do not place any flammable materials near the product.
-Do not open or remove the cover of the product.
-For electronic medical devices, special attentions regarding electromagnetic waves are
required.
-Modifying the product may damage it beyond repair and damage users and patients,
thus modifying and remodeling the product (including cables) is prohibited.
-Patients should be provided lead aprons for radiation protection
-Patients (children and pregnant women particularly) must wear lead aprons during their
X-ray imaging.
-Children and pregnant women must consult with their doctors before X-ray
examinations.
-When users or responsible agencies take particular examinations or treatments, there
might be serious hazard (e.g. noises) from the product itself.
-As the charger must be located and used at place, where users can easily connect and
disconnect it to the power supply. Keep the charger in place to use at the easily
accessible place.
-Users and patients are advised to use the hand-held x-ray equipment in accordance
with the method of use guided by Ionizing Radiations Regulations 1999(IRR99).
This X-ray unit may be dangerous to patient and operator unless safe
exposure factors, operating instructions and maintenance schedules are
observed.
It is important to read this user manual carefully and strictly abide by all
warnings and cautions stated within it.
To avoid risk of electric shock, this equipment must only be connected
to a supply main with protective earth.
Since rules and regulations concerning radiation safety differ between
countries, it is the responsibility of the owner and/or operator of this
equipment to comply with all applicable rules and regulations
concerning radiation safety and protection in their area.
Avoid touching the patient with equipment during X-ray exposure

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Especially for pregnant women, it is recommended to use personal dosimetry and a
lead apron
- 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.
-The Backscatter Shield : In addition to the radiation shielded cone, the back scatter
shield provides additional protection to the operator.
-DO NOT attempt to remove the backscatter shield. Attempting to do so will result in
damage to your device.
-The equipment can be used at an altitude of less than 3,000 meters.
-WARNING: Use of this equipment adjacent to or stacked with other equipment should
be avoided because it could result in improper operation. If such use is necessary, this
equipment and the other equipment should be observed to verify that they are
operating normally.
-WARNING: Use of accessories, transducers and cables other than those specified or
provided by the manufacturer of this equipment could result in increased
electromagnetic emissions or decreased electromagnetic immunity of this equipment
and result in improper operation.
-WARNING: Portable RF communications equipment (including peripherals such as
antenna cables and external antennas) should be used no closer than 30 cm (12
inches) to any part of the [ME EQUIPMENT or ME SYSTEM], including cables specified
by the manufacturer. Otherwise, degradation of the performance of this equipment
could result.
-WARNING: Failure to use this equipment in the specified type of shielded location
could result in degradation of the performance of this equipment, interference with other
equipment or interference with radio services.
-Metal substances or liquids shall not come into contact with the charger pogo-pins of
the product and the charging cradle.
Radiation Safety
- This equipment should be operated by a trained and qualified Dentist or a Dental
hygienist in a controlledenvironment.
- All users and patients should wear protective equipment, such as a lead apron
which is covered until collar.
When using the equipment, it is recommended that all users comply
with the following radiation safety guidance for the safety of the users
and the patients.

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- This equipment should be operated in the area that is more than 6 feet away from
other personnel, such as assistants or other patients. If they should stay closer than
6 feet, it is recommended that they wear a lead apron, thyroid collar, or stay behind
a lead shield.
- Pregnant women should not be exposed to X-rays unless it is strictly necessary.
- All users should comply with the Radiation Protection Policies established by the
government.

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2.3 Using Super Capacitor
- Make sure to charge the super capacitor in the external environment from thepatient.
- Make sure to use the super capacitor only provided or approved by NANORAY. If non-
standard or damaged super capacitors are used, there is risk of fire andexplosion.
- Make sure to use the cradle only provided or approved by NANORAY. Using an
unauthorized cradle may result in super capacitordamage.
- DO NOT expose super capacitor to heat or fire. Avoid storage in direct sunlight.
- DO NOT short-circuit, crush, puncture, mutilate, or disassemble thesuper capacitor.
- DO NOT store super capacitor haphazardly in a box or drawer where they may short-
circuit each other or be short-circuited by other metalobjects.
- DO NOT remove the super capacitor from its original packaging until required foruse.
- DO NOT subject super capacitor to mechanicalshock.
- DO NOT make the super capacitor wet or let it be in water. Keep super capacitor clean
anddry.
- Keep the super capacitor away from children andpets.
- Seek medical advice immediately if the super capacitor has beenswallowed.
- DO NOT dispose of super capacitor with ordinary trash. Turn in discharged super
capacitor to local supply or discard or recycle super capacitor according to your local
government regulations.
- The super capacitor cannot be replaced by users.
- When charging the super capacitor, the exposure function is locked.
- DO NOT leave a super capacitor on prolonged charge when not inuse.
- If the equipment has not been used for long periods of time more than 2 hours, it is
recommended to charge the super capacitor before use.
- Be sure to turn off the equipment when not in use. This helps to ensure the life of the
super capacitor.
- If the equipment not in use has been turned on for long periods of time, the super
capacitor may be fully discharged.
2.4 Contraindication
- patients (children and pregnant women particularly) must wear lead aprons
during their X-ray imaging.

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2.5 Radiation Safety
•This X-ray device may be dangerous to operator, patient and
bystander unless safe exposure factors, operating instructions and
maintenance schedules are observed.
•Do not operate if the backscatter shield or collimator cone are
broken.
1) Ensure proper registration and compliance with any such regulation.
2) In implementing a radiation protection program, please consult any state, provincial,
and local regulations governing radiation protection and the use of X-ray equipment.
3) Operator must follow all applicable regulatory guidelines and in-house radiation
protection program in regard to patients and operators who are pregnant or expect to
become pregnant.
4) Operators must be fully acquainted with industry safety recommendations and
established maximum permissible doses.
5) Optimal operator radiation backscatter protection exists when:
-The backscatter shield is positioned at the outer end of the collimator cone,
-The backscatter shield is parallel to the operator,
-The backscatter shield is close to the patient,
-The patient tilts their head when needed to accommodate exposures,
-The operator remains within the Significant Zone of Occupancy immediately behind
the device shield.
6) Do not enable The Portable Dental X-ray (Model: CS 2400P) until patient and operator
Correct
placement
Safety
Green zone

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are positioned and ready for the exposure, reducing the likelihood of interruption and
preventing inadvertent exposure of anyone to X-rays.
7) Do not attempt an exposure if anyone else is positioned immediately behind the
patient (in line with the direction of X-ray emission). If others are assisting, then they
should wear protective covering.
8) An exposure can be terminated for any reason by abruptly releasing the depressed
trigger
9) As shown in the table below, maximum protection (green area) from backscatter
radiation (red area) exists when The Portable Dental X-ray (Model: CS 2400P) 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.
10) Operation outside the protection zone (or with a diminished protective zone) requires
proper precautions such as the use of lead aprons.
11) Do not use low class image detectors.
(Film: higher than E class, Sensor: higher than 10 lp/mm, Phosphor plate: higher than
10 lp/mm)
*Comparative Data for Whole Body Exposure (Total Annual Operator Exposures)
Occupational Dose limit1
50 mSv
Occupational Dose limit Required Dosimetry1
5 mSv
Average Natural Background Radiation2
2.4 mSv
Average Occupational Radiation Exposure for Flight Crews3
2.19 mSv
General Public Dose Limit1
1.00 mSv
Range of Exposure for Dental Personnel Using Conventional X-
rays
2
0.20~0.70 mSv

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Average Exposure Using The Portable Dental X-ray (Model: CS
2400P) with D-Speed Film
4
0.03 mSv
Average Exposure Using The Portable Dental X-ray (Model: CS
2400P) with F-Speed Film or Digital Sensor
4
0.05 mSv
1) Standards for Protection Against Radiation, 10 CFR 20 (US Federal Standards), 1994
2) NCRP Report No. 145 (National Council on Radiation Protection and Measurements)
3) "Estimated Cosmic Radiation Doses for Flight Personnel", Feng YJ et al, Space Medicine and Medical Engineering, 15(4) 2002,
4)“Radiation Exposure with the Portable Dental X-ray(Model : CS 2400P),”Goren AD et al, Dentomaxillofacial Radiology, 37(2008), S.109-12;
Normalized average assumes 7,200 exposures per year, and the average length of exposure for D-speed Film = 0.40 sec, digital sensor =
0.15 sec.
* Comparative Data for Hand and Extremity Exposure (Total Annual Operator Exposures)
Occupational Dose limit1
500 mSv
Occupational Dose limit Required Dosimetry1
50 mSv
Average Exposure Using The Portable Dental X-ray (Model: CS
2400P) with D-Speed Film
2
0.32 mSv
Average Exposure Using The Portable Dental X-ray (Model: CS
2400P) with F-Speed Film or Digital Sensor
3
0.05 mSv
1) Standards for Protection against Radiation, 10 CFR 20 (US Federal Standards), 1994
2)Normalized average (includes leakage and backscatter radiation) assumes 7,200 exposures per year, and the average length of exposure
for D-speed Film = 0.40 sec, Digital sensor = 0.15 sec.
The CS 2400P is a portable dental X-ray for producing intra-oral image and operates on
14.5V DC supplied by a super capacitor.
The CS 2400P is composed of high voltage module including x-ray tubes and electric
circuits, main control unit, user interface and x-ray iris (collimator).
CS 2400P can be used with an intra-oral imaging sensor.
The CS 2400P is used for dental diagnosis in adult and pediatric patients and is available
3. System Overview