REMEDI IoDS-2401 User Manual

Intra-oral digital x-ray sensor

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User Manual

R-SENSOR

(Model name: IoDS-2401/IoDS-

2402)

Intra-oral Digital X-ray Sensor

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Summary of Contents for REMEDI IoDS-2401

Page 1 User manual User Manual R-SENSOR (Model name: IoDS-2401/IoDS- 2402) Intra-oral Digital X-ray Sensor...
Page 2: Table Of Contents
User manual Copyrightⓒ2018 Document Version 5 REMEDI Co., Ltd. #24232, 2F, 69-14, Sakju-ro 145beon-gil, Chuncheon-si, Gangwon-do, Korea Tel: +82-2-6930-5891 Fax: +82-2-6930-5892 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.
Page 3: About User Manual
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...
Page 4: Cautions
User manual company. In the event of loss of or damage to this User Manual, please contact to service center of REMEDI Co., Ltd.. This User Manual describes the precautions and possible risks that the user should be aware of and give attention to prior to use the IoDS-2401/2402.
Page 5: Precautions
Please read and understand the instructions carefully and then use your device. 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.
Page 6: General Prohibitions
User manual It can be provide any needed technical information to whom it may concern of maintenance service Do not pull the USB cable. Alerts the operator that failure to follow the procedure could cause damage to the equipment or cause loss of data.
Page 7: Appearance
3. Appearance 3.1 Intended Use - IoDS-2401/2402 is used for a radiographic examination by a dental professional to assist in the diagnosing 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, used once for one patient, and can be used for another patient by replacing the designated protective cover after use.
Page 8: Specification
Expected service life 7 years Essential performance No essential performance - Type: Standalone software (USB) Software for IoDS-2401/2402 - S/W name: REMEDIC - S/W version: V1.00 Harmonized Safety Standards Medical electrical equipment - Part 1: General requirements for basic safety...
Page 9: Product Description
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.
Page 10 User manual - Details size of IoDS-2402...
Page 11 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:...
Page 12 User manual ․ CMOS image sensor chip ․ Scintillator ․ Electronic substrate (electronic circuitry carrier + proximity electronics) ․ Flexible cable with end connector ․ Watertight housing ․ Shielding foils and shock absorbers...
Page 13 User manual - Cable ․ C onsists of PVC, ETFE, copper, plug connector and sensor connector ․ D iameter: ɸ3.7 ± 0.3 ․ L ength: 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).
Page 14: Accessory
User manual - 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.
Page 15: Storage And Transportation Condition
User manual - 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.
Page 16 User manual Keep away from sunlight Package Package EC representative Product Label Package Manufacturer Product Label Operating temperature range Product Label Storage temperature range Package Operating humidity range Product Label Storage humidity range Package Operating Atmospheric pressure range Product Label Storage Atmospheric pressure range Package Package...
Page 17: Label Of Package
User manual Sensor front > < Label location: 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.
Page 18: Pre-Procedure
User manual - 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.
Page 19 User manual - 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.
Page 20: How To Use
User manual - 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.
Page 21 User manual The sensitive area of the sensor is indicated by the arrows in the picture. The area outside of the gold line is not sensitive to x-rays. 4.5.1 Installation of Software Driver (1) Preparation Complete package of the R-Sensor includes follows. 1) R-Sensor 2) Software USB (2) Configuration of R-Sensor...
Page 22 User manual Menu Description R-Viewer Setup R-Viewer for single PC use Sensor_Driver R-Sensor device driver (4) Twain and device driver installation The TWAIN driver is provided under the terms of the contract and please contact your seller. (5) R-Viewer install 1) Connect the USB included with the product to your PC.
Page 23 User manual 5) The installation proceeds automatically in this order: Client, DB Server, and File Server. Note: The server consists of a DB server that manages information and a File server that manages images. 6) When the installation is complete, the screen below will be displayed and the PC will reboot when you click the [OK] button.
Page 24 User manual 5) Please press OK as below. 6) Click next.
Page 25 User manual 7) Click Yes 8) Click next.
Page 26 User manual 9) Click Finish and reboot to finish the installation.
Page 27 User manual (7) Image acquisition by using r-viewer 1) Patient Add and Search Mode ① Patient Information Input Window : Entering Patient Information to Add or Search ② Search and Add Button ③ Virtual Keyboard: Display Windows Virtual Keyboard 2) Patient Selection Mode The list of patients searched or added is displayed.
Page 28 User manual ① Patient List: Displaying a list of patients searched or added 3) Imaging and Viewing Mode View images of selected patients or take images of oral cameras or oral sensors. It consists of the patient's information display window, the image data list, the Periodical view and thumbnail, and the Image View window.
Page 29 User manual - Clicking on the Oral Sensor Filming button displays the Oral Sensor Filming window shown below. - After placing the sensor in the patient's mouth, the X-Ray is investigated and the image is automatically taken. - When the oral sensor has been successfully photographed, the images are displayed in the Periodical View as shown below.
Page 30: Shutdown Procedure
- Discard the wrap, clean the sensor, and store it in the designated location. - Turn off the PC. 4.7 After using this device Turn the PC power switch off and separate the USB cable of IoDS-2401/2402. Please contact our headquarters or a nearby sales representative for any problems with the device 4.8 Storage and Cleaning after use...
Page 31 User manual damage the sensors. Do the following(See picture below) • Use protective gloves for using, cleaning or disinfecting the sensor. • To disinfect the sensor head and the cable near the sensor head, wipe them with a cloth with 70% isopropyl alcohol after you finish using the product. •...
Page 32: Mechanical Damage Prevention
User manual Recommended storage when not in use Do not do the following(See picture below) • Sterilize the sensor using autoclave or UV oven. • Wipe the cable surface with a moistened compress with a disinfecting solution. • Immersion in bleach or an alcohol content solution. •...
Page 33: Protection From Electrical Damage
User manual Do not do the following(See picture below) • Pinch sensor or cable. • Pull or kink cable. • Unplug sensor by pulling on cable. • Remove protective sheath by pulling the cable. • Drop sensor. • Leave cable on the floor. •...
Page 34: Technical Data
Number of total pixels (H x V) 1000 pixels X 1506 pixels 1300 pixels X 1706 pixels Number of effective pixels 1000 pixels X 1500 pixels 1300 pixels X 1700 pixels Scintillator Type CsI(Tl)-12/GOS-62 Interface USB 2.0 - Effective photosensitive area of IoDS-2401...
Page 35 User manual - Effective photosensitive area of IoDS-2402 5.2 Exposure time chart Parts of tooth Classification Exposure time Exposure time set 0.2 – 0.3 s Adult 0.2 s Incisor 0.14 – 0.2 s Child 0.16 s 0.3 – 0.4 s Upper Adult 0.35 s...
Page 36 0.2 s 5.3 Image quality assurance - Image quality of the IoDS-2401/2402 sensor depends on several factors: • The quality of the X-ray source (kV, focal spot size, distance) • The alignment of the X-ray source to the anatomic region •...
Page 37: Maintenance
• Threshold level 250 mV 5.5 Portability - The IoDS-2401/2402 can be easily moved from one dental chair to another. Once disconnected from the USB port of the computer, the sensor may be positioned near a second dental chair and connected to a USB port nearby.
Page 38: Statement And Tables For Emc
User manual cause electrical hazards. 6.4 Maintenance - The IoDS-2401/2402 does not require any special maintenance other than regular cleaning and disinfection. - Clean your monitor screen, mouse and keyboard frequently. - Set monitor brightness and contrast properly. Be sure to use a video mode recommended for use with IoDS-2401/2402.
Page 39 User manual a) The interface between the PATIENT physiological signal simulation, if used, and the ME EQUIPMENT or ME SYSTEM shall be located within 0,1 m of the vertical plane of the uniform field area in one orientation of the ME EQUIPMENT or ME SYSTEM. b) ME EQUIPMENT and ME SYSTEMS that intentionally receive RF electromagnetic energy for the purpose of their operation shall be tested at the frequency of reception.
Page 40 User manual Not applicable 3 V m) Conducted 0,15 MHz – 80 MHz disturbances induced IEC 61000-4-6 6 V m) in ISM bands by RF fields c) d) o) between 0,15 MHz and 80 MHz n) 80 % AM at 1 kHz e) Not applicable 0 % UT;...
Page 41 User manual m) r.m.s., before modulation is applied. n) 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...
Page 42 User manual 3 V m) 0,15 MHz – 80 MHz Conducted disturbances induced IEC 61000-4-6 6 V m) in ISM bands by RF fields a) c) d) i) between 0,15 MHz and 80 MHz n) 80 % AM at 1 kHz e) Electrical transient conduction along supply ISO 7637-2...
Page 43 User manual Not applicable ELECTROSTATIC IEC 61000-4-2 ± 8 kV contact DISCHARGE c) ± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air Not applicable 3 V b) 0,15 MHz – 80 MHz Conducted disturbances IEC 61000-4-6 induced by RF fields a) 6 V b) in ISM bands between 0,15 MHz and 80 MHz...
Page 44: Product Warranty Policy
User manual Not applicable ELECTROSTATIC IEC 61000-4-2 ± 8 kV contact DISCHARGE e) ± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air Electrical fast Not applicable transients / IEC 61000-4-4 ± 1 kV bursts b) f) 100 kHz repetition frequency Surges a) b) g) Not applicable...
Page 45 Tel: +82-2-6930-5891, Fax: +82-2-6930-5892, E-mail: sales@remedihc.com Homepage: http://www.remedihc.com REMEDI Co., Ltd. homepage is available to you and provides a page where you can let us know if you have any complaints. If you have experienced any inconveniences during the use of our product or have any suggestions for improvement, except for product defects, please feel free to contact us and help us incorporate your ideas.
Page 46 User manual Contact: Tel: +49 6196 4021549, Email: info@javitech.de...

This manual is also suitable for:

Iods-2402