Manual de Usuario RVG
Manual de Usuario RVG
Table of Contents
1. Scope of Sensor .........................................................................................4
2. Symbols....................................................................................................5
3. Introduction ...............................................................................................6
3.1 Scope of Application ...........................................................................6
3.2 Safety Instructions...............................................................................6
4. Product Installing.......................................................................................8
4.1 Connecting the Sensor to the Computer T erminal....................................8
4.2 Software Installing ..............................................................................9
4.3 Sensor Mounting ...............................................................................14
5. Software Introduction ...............................................................................16
5.1 Software Interface Introduction...........................................................16
5.2 Patient Medical Record Menu.............................................................18
5.3 Oral X-ray Image Acquisition Menu....................................................19
5.4 Oral X-ray Image View Menu.............................................................21
5.5 Oral Diagnostic Report Menu .............................................................23
6. Operating Instructions...............................................................................25
6.1 Acquiring oral X-ray image................................................................25
6.2 Importing existing oral X-ray images...................................................28
6.3 Image quality optimization .................................................................31
6.4 Report Generation .............................................................................31
7. Recommended X-ray Source Parameters and Exposure T ime........................34
8. Maintenance............................................................................................35
9. Troubleshooting.......................................................................................37
10. Technical Data .......................................................................................39
11. EMC Tables...........................................................................................40
12. Statement ..............................................................................................46
Page 3 / 47
1 Scope of Sensor
1. Scope of Sensor
1. Sensor
2. USB Flash Driver
3. Sensor Mounting Bracket
4. Disposable Sleeve
5. Computer Terminal(Pad and its support, optional)
1 2 3
4 5
Page 4 / 47
2 Symbols
2. Symbols
If the instructions are not followed properly, operation may lead
WARNING
to hazards for the product or the user/patient.
Serial number
Catalogue number
Manufacturer
Date of manufacture
Class Ⅱ
BF type device
Keep dry
55 C
Temperature limitation
20 C
80%
Humidity limitation
20%
106kPa
Manufacturer’s LOGO
CE marking
0344
E C REP Authorized Representative in the European Community
Page 5 / 47
3 Introduction
3. Introduction
3.1 Scope of Application
NanoPix1-P is used in combination with a dental X-ray transmitter for medical
units to perform dental X-ray photography.
T his device must only be used in hospital environments, clinics, or dental
offices by qualified dental personnel.
3.2 Contraindications
Patients and operators of cardiac pacemakers should use it with caution.
Pregnant women are prohibited from using it.
WARNING
Page 6 / 47
3 Introduction
approval.
2. T he device must not be placed in humid surroundings or anywhere where it can
come into contact with any type of liquids.
3. Do not expose the device to direct or indirect heat sources. T he device must be
operated and stored in a safe environment.
4. T he device requires special precautions concerning electromagnetic compatibility
(EMC) and must be installed and operated in strict compliance with the EMC
information. In particular, do not use the device in the vicinity of fluorescent lamps,
radio transmitters, remote controls and do not use this system near the active HF
Surgical Equipment in the hospital. 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 NanoPix1-P, including cables
specified by the manufacturer. Otherwise, degradation of the performance of this
equipment could result.
5. Do not operate or store at high temperatures.
6. If irregularities occur in the device during treatment, switch it off. contact the
agency.
7. Never open or repair the device yourself, otherwise, void the warranty.
8. T he dental team should not rely on a single precautionary strategy. When using
the NanoPix1-P, the following universal precautions should be followed routinely
for adequate protection.
- Universal barrier precautions (such as masks, gloves and eye protection)
should be followed;
- A preprocedural rinse should be used before treatment;
- A rubber dam should be used where possible.
Page 7 / 47
4 Product Installing
4. Product Installing
4.1 Connecting the Sensor to the Computer Terminal.
Step Graphic Example Description
Page 8 / 47
4 Product Installing
T he picture of the connection between the sensor and the computer terminal.
2. Hardware requirements
CPU ≥ 1.0GHz
Memory ≥ 2GB
Page 9 / 47
4 Product Installing
Step 1:
Step 2:
Click
and confirm, the
computer terminal
pops up a dialog box
on the right
Page 10 / 47
4 Product Installing
Step 3:
Click
and accept the
agreement to
continue to the next
step.
Step 4:
T he software pops
up a dialog box on
the right, click
, to
indicate successful
driver installation.
Page 11 / 47
4 Product Installing
4. Dependency library installation
Step 1:
Open USB
flash driver,
double click
Step 2:
Click
,
When the
software pops
up a prompt
box, click
Page 12 / 47
4 Product Installing
Step 3:
Click
, Software
installed
successfully
Step 1:
Copy in
the USB driver to the
hard disk of the
computer terminal,
and open it.
Page 13 / 47
4 Product Installing
Step 2:
Right-click
in the folder to create
a desktop shortcut.
Step 3:
find on the
computer desktop,
double-click the
NanoPix shortcut to
run the software.
Page 14 / 47
4 Product Installing
Page 15 / 47
5 Software Introduction
5. Software Introduction
5.1 Software Interface Introduction
Click the icon on the desktop to start the software, and its home page
interface is as shown in the figure below:
Page 16 / 47
5 Software Introduction
Page 17 / 47
5 Software Introduction
or recently viewed diagnostic data.
Page 18 / 47
5 Software Introduction
Page 19 / 47
5 Software Introduction
ACQ UISITION: Click it and enter the oral X-ray Image
Acquisition Menu interface.
TEETH LAYO UT: use to determine the age group: adult or child.
Page 20 / 47
5 Software Introduction
5.4 Oral X-ray Image View Menu
VIEWER: Click it and enter the Oral X-ray image View Menu
interface.
Reset.
Page 21 / 47
5 Software Introduction
Ellipse:Pplace ellipse.
Grid.
Capture: Screenshot
1. BRIGHTNESS & CONTRAST: Adjust image brightness and
contrast;
2. Sharpen & Ultra Sharpen: Adjust image sharpness;
3. Reset: reset image.
Page 22 / 47
5 Software Introduction
X-ray image list: Double-click the X-ray image in the list to display
it in the display area.
New report
Delete page
Page 23 / 47
5 Software Introduction
Print Setting
Fit horizontal
Fit vertical
TEMPLATE: Use to select a template for generating a medical
record report.
REPO RT HISTO RY: Use to save the generated report and import
the existing report.
Page 24 / 47
6 Operating Instructions
6. Operating Instructions
6.1 Acquiring oral X-ray image
1. Open NanoPix software.
Page 25 / 47
6 Operating Instructions
TEETH LAYO UT .
Page 26 / 47
6 Operating Instructions
6. Press the exposure button to complete the collection, the interface displays the
acquired X-ray image (Figure A is only for illustration, this product does not
include this part)
Figure A Figure B
Page 27 / 47
6 Operating Instructions
WARNING
Page 28 / 47
6 Operating Instructions
to import existing X-ray images( jpg, jpeg, png, bmp, and dcm file).
Page 29 / 47
6 Operating Instructions
WARNING
Page 30 / 47
6 Operating Instructions
6.3 Image quality optimization
T he image quality optimization currently supported by NanoPix includes
brightness, contrast, sharpening, super sharpening, smoothing, and inversion. The
user can optimize the acquired X-ray image in the VIEW interface.
WARNING
Page 31 / 47
6 Operating Instructions
3. Click the report to enter the oral diagnostic report interface, select
Page 32 / 47
6 Operating Instructions
4. According to the actual needs, use the upper toolbar to edit the report, including
creating a new report, adding a page, deleting a page, adding an image box, adding
text box (optional); Finally, save and print the report.
Page 33 / 47
7 Recommended X-ray Source Parameters and Exposure T ime
NOTE
For larger body types: increase the exposure time(or Source current) by 25%
For children(5~21age): reduce the exposure time(or Source current) by 20%
For edentulous patients: reduce the exposure time(or Source current) by 20%.
WARNING
Since the X-ray exposure condition can be changed depending on the age, gender,
and bone density of the patient, in the case of Pediatric, X-ray exposure condition
can be changed by the expert's judgment.
Page 34 / 47
8 Maintenance
8. Maintenance
The Parts that need to be disinfected
Sensor Sensor Mounting Bracket
Wipe the surface of the part with gauze soaked in alcohol, A 70%-80% alcohol
content is recommended。
NOTE
WARNING
Page 35 / 47
8 Maintenance
Use a soft cloth soaked with clean water. If necessary, use a mild detergent, but
carefully remove any residue.
WARNING
1. When cleaning, pay attention to prevent liquid from seeping into the device
2. T he above parts should be placed in a dry and well-ventilated environment,
avoid being placed in a dusty or humid environment.
Page 36 / 47
9 T roubleshooting
9. Troubleshooting
When a problem or malfunction occurs, please check the machine with the
table below before contacting the dealer to quickly eliminate common problems or
malfunctions. If the problem or malfunction is not solved, please contact the dealer.
Problem or
Reasons & Solutions
malfunction
Check whether the connection between the sensor and
After triggering X-
the computer terminal is normal.
ray, no image is
Check if the sensor's X-ray receiver is facing the X-ray
displayed
generator.
Exposure time is too short, increase exposure time.
T he selected acquisition mode does not correspond to
the X-ray dose.
T he voltage of the high voltage generator is too low (less
T he X-ray image is than 60kVrms), check the high voltage generator.
dim and textured T he distance between the high voltage generator and the
patient is too far to match the selected dose.
Check the contrast and brightness settings of the
computer terminal to ensure that there is no problem
with the screen display.
T he exposure time is too long, shorten the exposure
time.
T he selected acquisition mode does not correspond to an
T he X-ray image is
X-ray dose.
too dark
Check the contrast and brightness settings of the
computer terminal to ensure that there is no problem
with the screen display.
T he X-ray image is
T he patient moves during exposure。
blurred
Page 37 / 47
9 T roubleshooting
Page 38 / 47
10 Technical Data
Page 39 / 47
11 EMC Tables
Page 40 / 47
11 EMC Tables
Electrostatic discharge +/- 8 kV +/- 8 kV Floors should be wood,
(ESD) IEC 61000-4-2 contact contact concrete or ceramic tile.
If floors are covered
+/- 2 kV, +/- 4 +/- 2 kV, +/- 4 with synthetic material,
kV, +/- 8 kV, kV, +/- 8 kV, the relative humidity
+/- 15 kV air +/- 15 kV air should be at least 30 %.
Electrical fast ±2kV ±2kV Mains power quality
transients/bursts 100kHz 100kHz should be that of a
IEC 61000-4-4 repetition repetition typical commercial or
frequency frequency hospital environment.
Surge Line to line: Line to line: Mains power quality
IEC 61000-4-5 ±0.5kV, ±1kV ±0.5kV, should be that of a
±1kV typical commercial or
Line to earth: hospital environment.
±0.5kV, Line to earth:
±1kV, ±2kV ±0.5kV,
±1kV, ±2kV
Voltage dips 0% UT ; 0.5 0% UT ; 0.5 Mains power quality
IEC 61000-4-11 cycle cycle should be that of a
at 0°, 45°
, 90°
, at 0°, 45° , typical commercial or
135°, 180° , 90°, 135° , hospital environment. If
225°, 270° , 180°, 225° , the user of devices
and 315° 270°, and require continued
315° operation during power
0% UT; 1 mains interruptions, it is
cycle and 70% 0% UT; 1 recommended that
UT ; 25/30 cycle and devices be powered
cycles 70% UT; form an uninterruptible
sine phase at 25/30 cycles power supply or a
0° sine phase at battery
0°
Note: UT: rated voltage(s); E.g. 25/30 cycles means 25 cycles at 50Hz or 30 cycles at 60Hz
Page 42 / 47
11 EMC Tables
Conducted dis-turbances 3V 3V Portable and mobile RF
induced by RF fields 0.15 MHz – 80 communications
IEC 61000-4-6 MHz, 6 V in equipment should be used
ISM bands be- no closer to any part of the
tween 0.15 NanoPix1-P, including
MHz and 80 cables, than the
MHz, 80 % AM recommended separation
at 1 kHz distance calculated from
the equation applicable to
the frequency of the
transmitter.
Page 43 / 47
11 EMC Tables
Page 44 / 47
11 EMC Tables
LTE Band 7
5240
WLAN
5100- Pulse modulation
5500 802.11 0.2 0.3 9
5800 217Hz
a/n
5785
WARNING
1. Use of accessories and cables other than those specified or provided by the
manufacturer of NanoPix1-P could result in increased electromagnetic
emissions or decreased electromagnetic immunity of NanoPix1-P and result
in improper operation.
Cable information:
Cable Name Cable Length(m) Shielded or not Remark
Power Cord 3 No /
Page 45 / 47
12 Statement
12. Statement
Service Life
T he service life of Sensor series products is 24 months.
Maintenance
MANUFACT URE will provide circuit diagrams, component part lists,
descriptions, calibration instructions to assist to SERVICE PERSONNEL in
parts repair.
Disposal
T he package should be recycled. Metal parts of the device are disposed as scrap
metal. Synthetic materials, electrical components, and printed circuit boards are
disposed as electrical scrap. Please deal with them according to the local
environmental protection laws and regulations.
Rights
All rights of modifying the product are reserved to the manufacturer without
further notice. The pictures are only for reference. The final interpretation rights
belong to CHANGZHOU SIFARY MEDICAL TECHNOLOGY CO., LTD. The
industrial design, inner structure, etc, have claimed for several patents by
SIFARY, any copy or fake product must take legal responsibilities.
Page 46 / 47
12 Statement
Add: NO.99, Qingyang Road, Xuejia County, Xinbei District, Changzhou City,
213000 Jiangsu, China
Tel: +86-0519-85962691
Fax: +86-0519-85962691
Email: ivy@sifary.com
Web: www.eighteeth.com
E C REP
Version: S01
IFU-6935002
Issued: 2020.07.16
All rights reserved.
Page 47 / 47