REMEDI IoDS-2401 User manual

User manual
User Manual
R-SENSOR
(Model name: IoDS-2401/IoDS-
2402)
Intra-oral Digital X-ray Sensor

User manual
Copyrightⓒ2018
Document Version 5
REMEDI Co., Ltd.
#24232, 2F, 69-14, Sakju-ro 145beon-gil, Chuncheon-si, Gangwon-do,
Korea
Tel: [phone] Fax: [phone]
This User Manual may be revised for the improvement of the product, without prior notification. Images in
this User Manual may differ from the actual product.
Table of Content
1. About User Manual ····································3
1.1 Cautions ········································3
1.2 Quality Assurance····································3
1.3 Revision History·····································3
1.4 Symbols ········································3
2. Precautions························································································································································································5
2.1 General Cautions ····································5
2.2 General Prohibitions···································6

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2.3 General warnings ····································6
3. Appearance ·······································7
3.1 Intended use ······································7
3.2 Specification ······································7
3.3 Product description ···································8
3.4 Appearance ······································9
3.5 Accessory ······································ 12
3.6 Operating condition ·································· 13
3.7 Storage and transportation condition··························· 13
3.8 Symbols ······································· 13
3.9 Labels of X-ray sensor ································· 15
3.10 Label of Package ·································· 15
3.11 ~ 3.12 Labels ···································· 15
4. How to use ······································ 16
4.1 Frequently used functions ······························· 16
4.2 Pre-procedure ···································· 16
4.3 Setup guidelines ··································· 16
4.4 Operation procedure·································· 17
4.5 How to Use······································ 18
4.6 Shutdown procedure·································· 29
4.7 After using this device ································· 29
4.8 Storage and Cleaning after use ····························· 29
4.9 Mechanical damage prevention ····························· 30
4.10 Protection from electrical damage ··························· 31
5. Technical data ····································· 32
6. Maintenance······································ 34
7. Statement and tables for EMC ······························ 35
8. Product warranty policy ································· 41
1. About User Manual
This User Manual is provided to the user along with the IoDS-2401/2402.
This User Manual only pertains to the IoDS-2401/2402 and does not serve for any other products of the

User manual
company. In theevent of lossof ordamage tothis UserManual, pleasecontact to servicecenter of REMEDI
Co., Ltd..
This User Manual describes the precautions and possible risks that the user should be aware of and give
attention toprior to usethe IoDS-2401/2402. Please read carefully all the precautions before you start using
the device.
Please refer to the Table of Contents to easily find the information that you need.
If you have any inquiries or need detailed information on the product, please refer to the contact information
or call our customer service center.
1.1 Cautions
This document contains proprietary information that is protected by copyright.
Under copyright law, this document cannot be reproduced, modified or otherwise amended without prior
approval.
1.2 Quality Assurance
The contents of this document may be revised without notification.
The company will not be responsible for any consequential problems, loss or damage arising from the use
of any performance specification or information that differs from the information contained in this User
Manual.
1.3 Revision History
The part numbers and revision number indicated in this document represent the current version.
The revision number will not be changed even if any sub-documents are revised.
The revision number may be changed when there is a major change in part numbers or technical
information in the document.
1.4 Symbols

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Symbols are indicated on the exterior, packaging of the product and in this User Manual.
The symbols represent important cautions and advice to the user. Please read the following symbols
carefully and be well informed of them for the use and storage of the product.
WARNING
This symbol represents “WARNING.” It is associated with possible matters
that may harm or cause irreversible damage to the product or the patient.
CAUTION
This symbol represents “CAUTION.” It is associated with possible matters
that may damage the product or harm the patient.
* This User Manual may differ from the actual product in terms of functionality.
* If deemed necessary, thecompany maymake any improvement to the product to enhance its performance,
without prior notification, and the company has no obligation to apply the same specification change to
the products already sold.
* This user manual is written in English.
* Countries other than English shall be produced in the language of the country in accordance with the
translation guidelines of REMED Co., Ltd.
2. Precautions
2.1 General Cautions
CAUTIONS
1.
Please read and understand the instructions carefully and then use your device.
2.
No modification of this equipment is allowed. If the product is modified or used for any purpose
other than those specified in this User Manual, REMEDI Co., Ltd. will not be responsible for the
safe operation of the device.
3.
Please check the sensor if not use for a long time

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4.
It can be provide any needed technical information to whom it may concern of maintenance
service
5.
Do not pull the USB cable.
6.
Alerts the operator that failure to follow the procedure could cause damage to the equipment or
cause loss of data.
7.
Do not continue to use the sensor if there is visible damage to the sensor housing and/or cable
8.
As the intra-oral sensor is situated inside the patient environment, your computer must
necessarily comply with standard IEC 60601-1, or your installation including the computer must
have been rendered compliant with standard IEC 60601-1. You can connect the sensor to your
computer without additional precautions once your complete installation is compliant with
standard IEC 60601-1.
9.
The sensor is an electrical medical device requiring special precautions regarding
electromagnetic compatibility. Please observe the recommendations in this manual during the
commissioning and use of the equipment.
10.
The sensor must be handled with care, minimizing the twisting, pulling and bending of the
attachment cable. Do not step or roll on the cable. Do not pull on the cable itself but on the
connection plug to disconnect the USB cable.
11.
To avoid interferences in the image, do not use the system close to strong magnetic fields and
avoid proximity to electrostatic emission sources.
2.2 General Prohibitions
PROHIBITIONS
1.
Do not use it out of intended use.
2.
Do not attempt to modify the unit.
2.3 General warnings
WARNINGS
1.
This device should be used in accordance with doctor's instructions and instruction.

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2.
The other equipment may malfunction due tothe electromagnetic waves generated by this device.
This device may malfunction due to electromagnetic interference generated by other equipment.
Do not use it adjacent to other equipment or load other equipment do. Do not connect the USB
cable to supply mains with wet hands.
3.
This device must be used by the intended user. Patients and users may be at risk from a variety
of hazards when using the device by someone other than the intended user.
4.
If intentionally ignore the cautions, warnings, and safety signs specified in this manual, patient and
user may be at risk from various hazards.
5.
Alerts the operator that failure to follow the procedure could cause bodily injury or death.
3. Appearance
3.1 Intended Use
- IoDS-2401/2402 is used for aradiographic examination by a dental professional to assist in thediagnosing
of diseases of the teeth, jaw and oral structures.
- IoDS-2401/2402 is located in the patient's mouth and used together with a separate medical device, X-
ray generator, usedonce forone patient, and canbe used for anotherpatient by replacing the designated
protective cover after use. IoDS-2401 / 2402 should only be used by dentists.
- Patient group
Age: Not relevant
Health: Not relevant
Patient condition: Not relevant, However, that special care must be taken to ensure safety when the
system is used to examine pregnant patients.
Patients who require radiographic imaging to diagnose diseases
Medical radiation exposure of pregnant woman is in accordance with ICRP-60 5.3.3
Radiation exposure against the pregnant woman executes only in case that it is necessary.
Abdominal radiation does are limited to less than 2 mSv when used in pregnant women
- Disease to be diagnosed: To diagnose diseases of the patient's teeth. (Example: Caries, tooth
arrangement, etc)

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3.2 Specification
Product name
Intra-oral digital X-ray sensor
Brand name
R-SENSOR
Model
IoDS-2401, IoDS-2402
(Model name is different according to the sensor head size.)
Classification
Class IIa (Annex IX, Rule 16, Council Directive 93/42/EEC as
amended by Directive 2007/47/EC)
Protection type from electrical shock
- ClassⅡequipment
- B type Applied part
Rating
5 Vd.c., 0.5 A (via USB cable connected to PC)
Expected service life
7 years
Essential performance
No essential performance
Software for IoDS-2401/2402
- Type: Standalone software (USB)
- S/W name: REMEDIC
- S/W version: V1.00
Harmonized Safety Standards
IEC 60601-1:2012
Medical electrical equipment - Part 1: General requirements for basic safety
and essential performance
IEC 60601-1-2:2014
Medical electrical equipment - Part 1-2: General requirements for basic safety
and essential performance - Collateral Standard: Electromagnetic
disturbances - Requirements and tests
IEC 60601-1-6:2013
Medical electrical equipment - Part 1-6: General requirements for safety -
Collateral standard: usability
IEC 62366-1:2015
Medical devices - Part 1: Application of usability engineering to medical
devices

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3.3 Product description
- An X-ray image sensor is positioned in the patient’s mouth just like Intra-oral film. There is no electrical or
physical connection between IoDS-2401/2402 and the x-ray generator. Images are automatically
acquired when x-rays are present in a dose which is perceptible to the sensor.
- Digital x-ray images are quickly displayed on the screen. Images can be optimized for viewing via imaging
software, stored as image files. Specified software is one example of a dedicated software that employs
a number of utilities for optimizing viewing and printing of images.
- REMEDI offers technical support for this device to ensure proper operation and to answer any questions
regarding the function of the device.
- The type of x-ray systemsthat integrate with theIoDS-2401/2402 are wall-mounted x-ray generators (both
AC and DC) with a tube current between 1 and 15 mA inclusive, and with a tube voltage between 50 and
100 kV inclusive, with in-built controls to set exposure parameters. Generators allow variable mA/kV to
be selected, all will control the exposure time.
- This device and software cannot act as an x-ray generator controller. All control of x-ray generation is
done by controls built into the generator itself. There is no connection between the subject device and
the x-ray generator. The subject device does not control the generator, it is a receiver.
- IoDS-2401/2402 must be connected to a PC through the standard USB 2.0 port.
3.4 Appearance
- Details size of IoDS-2401

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- Details size of IoDS-2402

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.
- The IoDS-2401(Sensor1) and IoDS-2402(Sensor2) are CMOS area image sensors developed for X-ray
imaging. The image sensors have a monitoring photodiode for monitoring and detecting X-ray irradiation.
FOP(fiber optic plate) used as the input window ensures high image quality and long sensor life even
under exposure to X-rays.
- The IoDS-2401/2402 supports USB 2.0. These sensors are designed to be water proof, equivalent to
IPX7.
- The intra oral sensor includes the following sub elements:

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․CMOS image sensor chip
․Scintillator
․Electronic substrate (electronic circuitry carrier + proximity electronics)
․Flexible cable with end connector
․Watertight housing
․Shielding foils and shock absorbers

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- Cable
․Consists of PVC, ETFE, copper, plug connector and sensor connector
․Diameter: ɸ3.7 ± 0.3
․Length: 2 / 2.5 meters
- Housing
․Housing material is ABS and the flammability is HB if YK-94(UL File No. 49895). The color
sample of the finished ABS housing is: CABS- 7247C (Black).
․Envelope protection rating: IPX7 (7=Protected against the effect of immersion between 15cm
and 1m).
- X-ray protection
․The rules of dental radiography still apply to digital x-ray systems. Please continue to use
protection for your patients. As a clinician, clear the immediate area when exposing the sensor.

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- Prevention of Cross-Contamination
․To help prevent cross-contamination between patients, place a new hygienic barrier on the sensor
for each new patient. The hygienic barrier must cover the sensor and at least 3-4 inches (7-10 cm) of
the cable.
3.5 Accessory
①Sensor holder
- An instrument that hangs the sensor after using the sensor
- size: 42 ✕50 mm
- weight: 27g
②USB : USB with program
- It is install on a PC and display the signal transmitted from the sensor on the monitor to process the
image.
- size: 18 ✕41 mm
- weight: 3g
3.6 Operating condition
- Temperature: 0 ℃~ 35 ℃
- Related Humidity: 30 %R.H. ~ 75 %R.H. (Non-condensing)
- Atmospheric pressure: 76 kPa ~ 106 kPa
- Altitude: Less than 2,000 m

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- Incident X-ray energy: 20 kVp ~ 90 kVp
3.7 Storage and transportation condition
- Temperature: -20 ℃~ 70 ℃
- Related Humidity: 10 %R.H. ~ 90 %R.H. (Non-condensing)
- Atmospheric pressure: 76 kPa ~ 106 kPa
3.8 Symbols
The following are descriptions of the symbols located on the outside and packaging of the product.
Please read carefully before using the product.
No
Symbol
Description
Location
1
Serial Number
Product Label
2
Date of manufacture
Product Label
3
TYPE B applied part
Product Label
4
Follow instructions for use
Product Label
5
General Caution, Warning (safety sign)
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6
General Prohibition (safety sign)
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7
Alternating current
Product Label
8
Keep dry
Package

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9
Keep away from sunlight
Package
10
EC representative
Package
Product Label
11
Manufacturer
Package
Product Label
12
Operating temperature range
Product Label
13
Storage temperature range
Package
14
Operating humidity range
Product Label
15
Storage humidity range
Package
16
Operating Atmospheric pressure range
Product Label
17
Storage Atmospheric pressure range
Package
18
WEEE Mark
Package
Product Label
19
CE marking
Package
Product Label
3.9 Labels of Sensor(Laser printing)

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< Label location: Sensor front >
3.10 Label of Package
3.11 Applied part symbol
- (B type applied part) symbol was marked on the label
4. How to use (Start-up and Shutdown procedure)
4.1 Frequently used functions
- Check the sensor head for damage.
- Cover the sensor head with a wrap.
- Determine the location to exposure X-ray and place the sensor on the tooth to be imaged.
- Enter patient information or search for a patient.
- Operate the image. (Magnification, rotation, inversion, length measurement, etc.)
- Save the image.

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- Remove the sensor from the patient mouth.
- Discard the wrap, clean the sensor, and store it in the designated location.
4.2 Pre-procedure
- Check the patient’s condition.
- Put a wrap on the sensor.
- Determine the location to exposure X-ray.
- The Protective sheath uses 100L / 100S products from a licensed Pac-Dent International, Inc.
(Pac-Dent International, Inc FDA 510K No. K151123)
4.3 Setup guidelines
- The computer and the screen with which the sensor is connected to should preferably be
situated close to the chair, within the field of vision of the practitioner, to allow for immediate use.
This will allow the practitioner to provide visual access to the patient and be able to share the
radiological information with him/her.
- The screen must be placed so as to avoid any reflections or direct overhead illuminations that
could be detrimental to the visualization of the radiological images. It must be set up (contrast and
brightness) to display as many grey levels as possible in the image.
- The x-ray generator has a great influence on the quality of the acquired images. The IoDS-
2401/2402 is compatible with any kind of generator, be it high-frequency or conventional. The
generator must be equipped with an electronic timer (allowing for very short exposure times) and
must emit a dose sufficient for the acquisition of a good image (with sufficient contrast). Make sure
that your x-ray generator is in good repair and has been calibrated and tested recently (as per your
states regulation). The energy emitted by a generator diminishes over time; when in doubt have
your generator checked by a qualified technician.
4.4 Operation procedure
4.4.1 Precautions for Sensor

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- Make sure the sensitive surface (the flat surface) of the sensor is directed towards the x-ray
generator. The back of the sensor (rounded) does not react to x-rays and does not produce an
image on-screen.
- The sensor must be manipulated with care, minimizing the twisting, pulling and bending of the
attachment cables. Do not step or roll on the cable.
- Even though the sensor is resistant to impacts, it is strongly recommended to not let it fall on the
floor. If a physical impact should happen, contact your distributor and do not try to intervene
yourself.
- Do not tell the patient to bite on the sensor or cable. Instead, ask the patient to close their mouth
around the sensor and relax the muscles of the jaw.
4.4.2 Precautions for Use

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- Use a disposable sterilized cover to avoid various infections among patients.
- Check whether the product operates properly before using. Do not use the product when there is
something wrong before using. Stop using the product immediately when it is found to be in fault
while in use, such as overheating or cracking.
- Do not modify or overhaul the product by yourself.
- Verify your own application software. Improper command sequence, improper arguments and
any other improper operation may result in unintended behavior.
- Do not twist, bend, pull and pinch the cable strongly. These actions can cause damage to the
cable.
- Connect and disconnect the USB connector by holding the body of the sensor, never pull it by the
cord.
- Check that the USB connector is not wet and dirty before you connect it.
- Do not touch the pins of the USB connector because the product can be damaged due to static
electricity.
- Do not drop or strike the product.
- Do not apply any pressure (example, tight holders or biting) on the product because it might be
damaged.
- Obey local laws when you use or dispose the product.
- If you use the product beyond the estimated useful life, check the performance of the product
carefully before using.
- Take measures against computer viruses and verify antivirus measures.
4.5 How to Use
Only PCs that meet the specifications listed below should be used. Failure to do so may
result in equipment damage or unacceptable risk to the patient or operator.
- IEC 60950-1 approved PCs
- OS: Window XP, 7, 8, 8.1, 10
- CPU: Pentinum4 or better process
- RAM: at least 1 GB
- Storage: 200 MB for software, 40 GB for user database
- USB 2.0 or 3.0
Monitor resolution: at least FHD