TABLE OF CONTENTS 1 SAF INTRODUCTION SAFETY REQUIREMENT LABELING

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2 TABLE OF CONTENTS 1 SAF INTRODUCTION SAFETY REQUIREMENT LABELING WARNINGS AND INSTRUCTIONS SYMBOLS AND DETAILS WARNINGS FOR USE Warnings for product use Warnings for battery use Caution for product inspection WARNINGS FOR STORAGE CAUTION AND INSTRUCTIONS SYMBOLS AND DETAILS CAUTION AND INSTRUCTIONS Caution for product storage... Erreur! Signet non défini. 3.3 CAUTION OF OTHER MATTERS ITEMS TO CONFIRM SYMBOL AND DETAIL ITEMS TO CHECK PRODUCT FEATURES OUTLINE PRODUCT FEATURES Features PRODUCT SPECIFICATIONS Device main body Digital Sensor Battery Pack Battery pack charging adapter Battery charging cradle

3 6 PRODUCT COMPOSITION OUTLINE PRODUCT COMPOSITION PRODUCT EXPLANATION Main body name GUI screen composition and functions HOW TO USE POWER ON/OFF X-RAY RADIOGRAPHY X-Ray panel and exposure Oral sensor connection check X-RAY exposure time setting Sensor Direction Setting Image Processing Parameter X-RAY exposure X-RAY image processing CAMERA PHOTOGRAPH Camera panel and photograph Intra oral Camera photography FILE MANAGEMENT File manager NETWORK CONNECTION Preparation before connection AP(ACCESS POINT) connection HOST program connection ENVIRONMENT SETTING Environment setting panel Save image format Environment setting Buttons Automatic Software Update HOST (SAF-MAN) PROGRAM HOST program installation Program run Program utilization WIRED REMOTE CONTROLLER Wired remote controller usage BATTERY Mounting battery inside Main body Battery level and charging

4 8 MAINTENANCE AND STORAGE METHOD MAINTENANCE AND STORAGE STORAGE METHOD Check for Product storage Product Storage Charger and cradle storage ITEMS TO CHECK Daily Inspection Items Monthly Inspection Items Yearly inspection items INSPECTION ITEMS BEFORE REPAIR REQUEST CONFIRM ITEMS BEFORE REQUESTING INSPECTION PRODUCT SPECIFICATION AND QUALITY ASSU PRODUCT SPECIFICATION SAF-4000 TECHNICAL DOCUMENT HIGH VOLTAGE GENERATOR X-RAY Tube : D-081B ELECTROMAGNETIC COMPATIBILITY RADIATION PROTECTION PRODUCT LABEL PRODUCT TRANSPORTATION, STORAGE CONDITIONS AND CONDITIONS OF USE Transportation and storage conditions Optimal conditions of use

5 1 SAF Introduction Thank you for purchasing Safari s digital X-RAY radiography device. SAF-4000 digital X-RAY radiography device (Digital Radiography System) is a product developed to integrate the use of all existing digital X- RAY image radiography devices. With features such as built-in 4.8 inch touch panel TFT-LCD monitor, user friendly UI (User Interface), and simple manipulation, SAF-4000 provides users with real time image check, and various image handling functions, and through USB, universal interface types of sensors can be applied and high-end quality image can be obtained, processed, and transmitted. PRODUCT USAGE This product is a medical device, and it should only be used as digital X-RAY radiography device for X-RAY radiography at corresponding hospitals. B TYPE MOUNTING PART In general, B type mounting part is a product proper for making contacts with patients external body or internal body parts except heart. CAUTION For proper usage and safety purposes, please ensure that only legally qualified personnel can use this product after fully familiarize with contents of user manual. 1.2 Safety requirement labeling SYMBOL NAME DETAIL Warning Caution Check "Warning" sign explains details of possible user damage, death or physical damage. "Caution" sign explains details of possible body damage due to incorrect use of product. "Check" sign explains details of necessarily items that users should follow in product installation, oepration, and maintenance

6 2 Warnings and instructions 2.1 Symbols and details "Warning" sign explains details of possible user damage, death or physical damage. 2.2 Warnings for use Warnings for product use Please ensure not to exceed X-RAY exposure dose required for image diagnosis. When using device, if radiation exposure safety regulations and operation related guidelines are not followed, both patients and operators can be at risk. Only legally qualified personnel can operate this device. Please use this device only for designated purpose. When using this device, if any abnormalities are found with the patients, please stop using the device, and ensure the safety of patients. Please do not randomly alter the device while using. While using, if you suspect of breakdowns such as oil leakage, please turn off power immediately, and contact the closest customer support center. Make sure fire extinguisher is onsite for fire emergency Warnings for battery use If non-standard batteries are used, there is danger of battery explosion. Avoid strong shocks to batteries and avoid penetration to batteries with sharp objects. If batteries are kept under high temperature, there is danger of battery explosion. Do not make batteries wet or let batteries be in water. Keep and store batteries away from children and pets. Please do not put metallic substance to battery terminals or disassemble as it may cause explosion. Please do not let charge terminals come into contact with metallic substance

7 2.2.3 Caution for product inspection Do not touch product, charger, and power plug with wet hands, otherwise, there is danger of getting electrical shocks. During cleaning process of product, do not use wet wiping clothes, or spray. Also, please only do cleaning after separating batteries from device. 2.3 Warnings for storage Moisture, salinity, dust, and etc. can affect the performance of device, therefore, do not store device in places with such conditions. Do not store product in places with frequent temperature changes or direct sunlight for long period of time. Do not store product together with explosive gas or chemicals. Do not leave battery pack connected with charger during storage. Do not leave digital sensor connected with SAF-4000 during storage. Digital sensor is a very sensitive device, please keep it separately in storage case

8 3 Caution and instructions 3.1 Symbols and details "Caution" sign explains details of possible body damage due to incorrect use of product. 3.2 Caution and instructions Caution for product use Please maintain regular temperature and moisture level for normal operation. During using or transporting the device, please be careful to avoid severe shocks or vibration. Please wear apron protected with lead or equivalent radiation protection gear Please do not put in dusty, dirty, or tilted place while using. Do not pull out connection cable of battery pack cradle and charger unreasonably since it can become cause of breakdown. Please be familiar with how to use digital sensor in advance. 3.3 Caution of other matters In case of device breakdown, mark properly and be sure to leave it to designated professional at A/S center. Do not let patients touch the device randomly, and keep it away from patients' hands. When discarding product, This sign indicates that electronic product should not be thrown away as regular garbage or recyclables. It may be dangerous to discard this product without treatment. Please contact with retailer or waste treatment company

9 4 Items to confirm 4.1 Symbol and Detail 4.2 Items to Check "Check" sign explains details of items that must be followed for product installation, operation, and maintenance. Please check battery pack and device condition, and confirm device operates accurately before using. Please ensure to double check the part that directly makes contact with patients. Please use device with designated sequence. Please use device at stable place with good ventilation. Please ensure to keep digital sensor in exclusive case after use of device. Also, confirm display lamp of remaining battery power, and if remaining battery power is not sufficient, please recharge the battery. Please use exclusive charger only when charging battery pack. Be sure not to let metallic products and other foreign substance touch battery pack terminal, and keep it clean by using dry clothes. Be sure to use device and parts after receiving regular inspection

10 5 Product Features 5.1 Outline In Chapter 5, features and specifications of this device are explained for safe use. 5.2 Product Features Features Medical Device Name: Portable Mobile Dental X-RAY System Model Name: SAF-4000 CPU: 1.6GHz Display: 4.8 Touch Panel TFT-LCD (1024x600) Memory: Internal SSD: 4GB, External FLASH Memory: 16GB Software: Self manufactured, UI and image capture, and handling possible Exposure: Within 0.05 ~ 1.35 second range, exposure possible by 0.01 second increment Battery: Use rechargeable 4 Cell high capacity battery pack Interface: Use USB Product specifications Device main body Rating: Class II Tube voltage: 60kV(Fixed) Tube current: 2mA(Fixed) X-RAY tube focal spot size: 0.8mm Voltage Consumption: 240W Max. Cooling method: OIL Cooling Method Total filtering: Over 2.3mm Al (inherent filtration: 0.8mmAl, fixed type added filter: 1.5mmAl) Target Angle: 20 Time setting function: [sec.] Main body size: 240(L) x 166(W) x 82(H) [mm] Main body weight (including battery): 2.6kg

11 5.3.2 Digital Sensor (Optional) REX Sensor Active Pixel Array: 1650x1200(Pixel) Active Area: 33 x 24 (mm) Sensor type: Low Noise Hybrid CMOS Interface: USB2.0(High speed) Cable length: 3m Usage temperature: -20 ~ 60 Usage Humidity: 30% ~ 95% Air pressure: 700 ~1060 (hpa) REX Sensor Active Pixel Array: 1800x1300(Pixel) Active Area: 36 x 26 (mm) Sensor type: Low Noise Hybrid CMOS Interface: USB2.0(High speed) Cable length: 3m Usage temperature: -20 ~ 60 Usage Humidity: 30% ~ 95% Air pressure: 700 ~1060 (hpa) Battery Pack Model name: PF435060HP-4S Manufacturer: Hye-young Inc. Cell material quality: Lithium Polymer Charging condition: Charging current: 1A Charging voltage: 16.8VDC Temperature range: 0-40 Usage condition: Maximum current: 18A Output voltage: DC 15V Temperature range:

12 5.3.4 Battery pack charging adapter Model name: BPL910S16N01 Input voltage: VAC, 50/60Hz Input current: 1.8A Output voltage: DC 16.8V Output current: 1A Battery charging cradle Model name: D910 Charging voltage: 16.8V Charging current: 1.0A Size: 77.5(L)x72.3(W)x49.3(H) [mm] 6 Product composition 6.1 Outline In chapter 6, product parts and each part are explained. Please be familiar with this manual before start of use of device. 6.2 Product composition Main body: 1EA Battery pack: 2EA Battery charger: 1EA Battery charger cradle: 1EA Charger power cord: 1EA USB Connect cable: 1EA Touch pen: 1EA Assistant hand strap: 1EA Storage case: 1EA User Manual CD: 1EA Digital intra oral sensor: Each 1EA Wired remote controller: 1EA Mobile stand: 1EA

13 CHECK The composition images of products can be different depending on development of product functions and regulations and supplying circumstances in each country. Please consider it as a simple reference. Main body Battery pack Battery charger Battery charging Charger power cord USB Connect cable Touch pen Assistant handle Storage case (sold sepraratly) User Manual CD /Product Warranty Digital intra oral sensor Intra oral camera (sold separately) Wired remote controller Mobile stand

14 6.3 Product Explanation Main body name Each part name of main body is as following. 4.8 Touch Panel TFT LCD Power button Key pad Speaker hole PC Connector port cover Label Wired remote controller connection port Battery cover USB2.0 port for sensor X-RAY Exposure lamp Radiation Field

15 6.3.2 GUI screen composition and functions Name for each part on main screen Camera Connection Status Icon Oral Sensor Connection Status Icon Network Connection Status Icon Battery Status Icon X-RAY Selection Button ORAL CAMERA Selection Button File Manager Selection Button Network Connection Selection Button Environment Setting Selection button Name for each part on X-RAY Panel kv Display ma Display Currently Connected Oral Sensor Display Window Oral Sensor Status Window Oral Sensor Reset Button Sensor Direction Setting Button Exposure Time Display Window Image Processing Method Selection Button Exposure Time Setting Value Display Window Exposure Time Setting Value Adjustment Button

16 Name for each part on Camera Panel Real Time Image Screen Display Name for each part on File Manager Panel X-RAY Radiography Image Save List Navigation Button Camera Photography Image Save List Navigation Button

17 Name for each part on Network Panel Network Adjustment Panel Activation Button Device LOCAL IP Display Window HOST IP Input Window Communication Status Among Hosts Confirm Button Connection Port Display Window AP List Display Window Connection Status with Host Confirm Button AP Selection Connection Button Password Input Window AP List Search Button Network Enable or Disable Select Button Name for each part on Environment Setting Panel BMP Type Image Save Selection Button JPG Type Image Save Selection Button Camera Auto Start Selection Button Radiography Image Auto Send to Host Selection Button Radiography Image Screen Auto Fit Image Scale Selection Button DICOM Type Image Save Selection Button Sensor Standby Time Setting Button Automatic Software Update Button Use Sound Effect Selection Button

18 7 How to use 7.1 Power On/Off When opening LCD window panel cover and pressing power button for one second, power turns on with beeping sound, and operating system of embedded computer in product boots up, and manufacturer's logo as shown in Figure 7-1 appears. Figure 7.1 Manufacturer logo screen Figure 7.2 Main screen Two seconds after manufacturer's logo appears, main screen is activated as shown in Figure 7.2. Main screen consists of five buttons connected to X-RAY, Oral Camera, File manager, Network connection, and Environment setting panel. By touching the button of wanted item on LCD screen, it navigates to corresponding panel. If power button is being pressed for one second while operating, power button flickers with beeping sound, and after internal embedded computer shuts down(in about 30 seconds), power is shut off. CAUTION SAF-4000 has automatic power shut off function in order to reduce battery consumption. Automatic power shut off time is set for three minutes from the point of idling

19 7.2 X-RAY radiography X-Ray panel and exposure For X-RAY radiography, activate X-RAY panel as shown in Figure 7.3. For X-RAY panel, if sensor is not connected, it is possible to operate with X-RAY only. If oral sensor is not connected, user's desired Exposure Time parameters should be set with ready button pressed in order to activate SELF EXPOSURE status for exposure enabling (Refer to 7.2.3~6). Figure 7.3 X-RAY panel Figure 7.4 panel SELF EXPOSURE status If ready button is pressed without sensor, phrase as shown in Figure 7.4 appears. If aiming is complete, press Exposure button, and start exposure. If exposure starts, exposure is performed with beeping sound, at this moment, user should keep pressing Exposure button until exposure is complete. If button is released in the middle of exposure operation, X-RAY will be suspended

20 7.2.2 Oral sensor connection check Steps to perform radiograph connecting intra oral sensor are as followings. Prepare REX 2 sensor series intra oral sensor to connect SAF-4000, and use USB cable connected to intra oral sensor in order to hook up with USB2.0 PORT of SAF-4000 front part. After connected intra oral sensor, and press SENSOR RESET button of X-RAY panel. When connection is complete and SAF-4000 power is turned on, X-RAY panel status is as shown in Figure 7.5. Currently connected oral sensor and sensor serial number display Oral sensor connected status Intra oral sensor radiograph ready status Reconnection button of intra oral sensor not displayed Sensor Direction Setting Button Current detail information display of intra oral sensor Image Processing Method Selection Button Figure 7.5 Currently connected oral sensor and sensor serial number display As shown in Figure 7.5, if oral sensor is connected, intra oral sensor display is activated in green color at upper part of screen, and currently connected intra oral sensor name is displayed on DENTAL X-RAY panel SENSOR. If radiograph is possible with intra oral sensor connection completed, STATUS of panel center part turns into STANDBY status, and sensor detail status and information are displayed at lower part of screen

21 7.2.3 X-RAY exposure time setting DENTAL X-RAY exposure intensity of SAF-4000 is fixed as 60kV, 2mA, and based on exposure time adjustment, display can change. SAF-4000 X-RAY exposure time can be adjusted in the range of 0.05 sec. ~ 1.35 sec. Exposure time can be adjusted by 0.01 second increment. Using two buttons on left among four adjustment buttons, time can be adjusted by 0.1 second increment, and two buttons on right side by 0.01 second increment. Exposure time display Currently adjusted exposure time display Increase exposure Decrease exposure Decrease exposure Increase exposure time by 0.1 second time by 0.1 second time by 0.01 second time by 0.01 second increment button increment button increment button increment button Figure 7.6 Name of each part for exposure time adjustment Select desired exposure time, and press exposure time adjustment button in order to set corresponding value. Based on age, exposure area, and distance, general exposure time is determined. Time setting value based on radiograph portion is shown in Table

22 Table 7-1 Time setting table based on radiography area Classification Radiography area and expose time Classification by age Adult - - Children - - Distance between product and skin: At 0cm Sensor Film 0.10 ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ 1.0 ~ Distance between product and skin: at 5cm Sensor Film 0.15 ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ 1.25 ~ 1.35 CAUTION Time setting value based on radiograph area can have larger difference depending on sensor type, film, distance to patient, and image Sensor Direction Setting Left, Right, Upper, Lower buttons appear when you press direction button. Set up the direction by cable linked to the sensor and place it into the mouth and start taking images. The selected direction is indicated as L(LEFT), R(RIGHT), U(UP), D(DOWN) when image is generated

23 7.2.5 Image Processing Parameter SAF-4000 provides 3 kinds of image processing parameters. The values changed to P-660, P-661, P-664 when you click parameter button. Each image processing parameter has different brightness, contrast, gamma value so that user can choose by preference X-RAY exposure After completing all settings, confirm ready status of X-RAY generating tube before starting X- RAY exposure. If exposure ready status is complete, symbol of EXPOSURE STANDBY on right side of screen is activated to green color as shown in Figure 7.7. If exposure ready status is not complete, EXPOSURE STANDBY symbol is deactivated to gray color. 10 seconds after one round of exposure completion, EXPOSURE STANDBY symbol is activated to green again. Exposure ready is not complete Exposure ready is complete. Figure 7.7 X-RAY generating tube exposure ready status display If exposure ready is complete, press READY button on bottom part of right side and change to X-RAY exposure standby status as shown in Figure 7.8. If READY button is pressed, the button turns into red CANCEL button, and it will be standing by until X-RAY output is detected. Standby time can be set up within 5 ~ 180 seconds range, and setting can be done on SETUP panel (Refer to 7.6.3). If READY button is pressed and turned into X-RAY exposure standby status, panel navigation and setting change related buttons, except CANCEL button, are deactivated. After locating flat face of intra oral sensor to the closest distance inside radiograph target teeth, position radiation field of SAF-4000 parallel with sensor face, and to the closest distance possible

24 If aiming is completely, press remote button to activate exposure. Remote button should not be released until exposure is complete, and if button is released in the middle of exposure, exposure is suspended immediately. Exposure is started with a beeping sound, and EX button on front part of main body changes to yellow color. Figure 7.8 X-RAY exposure possible and standby status While on exposure, the process should go through two phases. Each status can be distinctive by beeping sound. o Phase 1: Exposure start notice - This is a melody section of beeping sound, exposure operation and tube heating time are notified o Phase 2: Under exposure notice - By continuous signal sound, exposure progress is notified. CHECK Since this product generates X-RAY only while keep on pressing button, if button is released in the middle of beeping sound, X-RAY generation is suspended. CAUTION Please do not radiograph with substance that can reduce X- RAY intensity between X- Ray radiation aperture and subject. CAUTION The case of oral sensor, please use only the specified products. If connected other sensors, can t obtain image and may affect the software system

25 Sometime after X-RAY exposure, obtained image as shown in Figure 7.9 is displayed on screen. Sensor Direction Display Radiograph image Image processing button Figure 7.9 X-RAY radiograph image and name of each part Radiograph date & time In general, since oral sensor size is smaller than X-RAY exposure area, if radiograph aimed at center area of oral sensor, entire image display is possible without missing radiography area X-RAY image processing After obtaining image as shown in Figure 7.9, for user desired image adjustment, press TOOL button on upper part of right side to navigate detail list as shown in Figure Name of each part for X-RAY image processing detail list is shown in Figure 7.10, includes buttons such as previous X-RAY panel navigation, image enlargement, image reduction, image reverse, image 90 rotation, brightness adjustment scrollbar, gamma value adjustment scrollbar, and original image conversion. Tasks such as X-RAY file name change and others can be done in file manager. Refer to "7.4.1 File manager" for details. Previous screen move button Brightness adjustment scrollbar Original image conversion button Gamma value adjustment scrollbar Image enlargement button Image reduction button Image reverse button Image rotation button Image save button Figure 7.10 X-RAY image processing detail list panel and name of each part

26 7.3 Camera photograph Camera panel and photograph Activate ORAL CAMERA panel for intra oral camera photograph. In case of windows OS based web camera for general use, applicable camera is possible for photograph with automatic recognition, and some other cameras can be operated by driver installation. SAF-4000 based software and hardware interworking camera includes i-cam intra oral camera. If camera is not connected, basic camera panel shape is as shown in Figure Figure 7.11 ORAL Camera panel screen (When camera is not connected)

27 7.3.2 Intra oral Camera photography Connect USB 2.0 interface and windows based camera for camera photograph. In case other driver installation is not required, the camera is recognized automatically, and if driver installation is required, contact with designated sales office or headquarter. Camera photograph is explained based on i-cam oral camera. i-cam intra oral camera composition is as shown in Figure After connecting intra oral camera with docking, connect USB port with SAF-4000 front side. If recognition is complete, image incoming from oral camera is displayed on camera panel as shown in Figure Oral camera (i-cam) Oral camera docking Image capture button High-intensity White LED and optical lens Figure 7.12 i-cam oral camera and name of each part To save image, touch twice on image of LCD window or use built-in image capture button of oral camera. Saved image file is stored in camera image folder in file manager, initially saved file name is stored in combined form of patient ID and photograph date and time. If image capture button is pressed for oral camera photograph, image shown on screen is captured and saved automatically. Initially saved file is named as combined form of photograph date and time. Camera connected status Figure 7.13 Image display screen of oral camera Camera image display screen

28 7.4 File Management File manager By pressing "File Manager" button from main menu or left side of the menu, display screen as in Figure 7.14 is shown Figure 7.14 File manager initial screen File manager screen is divided into two items, including X-RAY IMAGES and CAMERA IMAGES. X-RAY IMAGES item moves image radiographed from X-RAY panel to save folder and CAMERA IMAGES moves image photographed from CAMERA panel. Images are managed by moving file to file items. The third column of space represents recently images, when select image, the image can be moved to the edit screen. Move to image save folders by pressing arrow of each item. When navigating to save folder, X- RAY IMAGE file is listed up. The most recent radiograph file is shown first by order. CHECK SAF-4000 DICOM file save is possible only if X-RAY is radiographed. Photographed image by camera is saved in BMP or JPG format, and if DICOM is selected, JPG file type is used as default

29 7.15 X-RAY IMAGE file list For X-RAY IMAGES, and CAMERA IMAGES, file list forms of each item are the same. Therefore, X-RAY IMAGES item will only be explained in the manual. Name of each part for file list is as shown in Figure Switch the selected images to full screen Save new file name Delete selected file Image transmission to host program File list screen Scrollbar Figure 7.16 Name of each part of X-RAY IMAGES file list

30 If image file name to be changed is selected, and new file name save (RENAME) button is pressed, pop up screen as shown in Figure 7.17 is activated. Figure 7.17 Pop up window screen when selecting save new file name (RENAME) button If file name to change is input through virtual keyboard and OK button is pressed, file is saved under new name. At this moment, radiograph date and time and file type of latter part of file name remains the same. If need to delete file, select desired file, and press delete button. Then pop up screen as shown in Figure 7.18 is activated. Figure 7.18 Pop up screen in case delete (DELETE) button is selected If file to delete is confirmed, delete the file by pressing OK button. And check if corresponding file is deleted from list

31 If need to transmit file to HOST(SAF-MAN), select transmitting file and press host transmission (TO HOST) button, image is transmitted to HOST program wirelessly along with pop up window notifying transmitting status. Press TO HOST button after selecting transmitting image. If transmission is complete, transmission completion pop up window as shown in Figure 7.19 is activated. Refer to "7.5 Network connection" for connection method with host program. Figure 7.19 Image transmission completion screen to HOST program After image completion, HOST (SAF-MAN) program is shown as in Figure Various processing for received image is possible within host program. Refer to 7.7 HOST (SAF-MAN) Program how to use detail with host program. Figure 7.20 Image received by HOST program

32 7.4.2 File manager image processing Navigate to image processing panel of file manager to handle adjustment tasks such as enlargement, reduction, brightness, and gamma value. Image processing button Figure 7.21 File manager image processing panel If pressing twice of image to process, the image moves to image processing panel as shown in Figure Press image processing button on upper right part, and activate image processing detail list button as shown in Figure Image list panel conversion Brightness adjustment scrollbar Image enlargement button Gamma value adjustment scrollbar Image enlargement button Image reduction button Image reverse button Image conversion button Figure 7.22 File manager image processing panel

33 Image enlargement / reduction o Press image enlargement button and enlarge image to desired size as shown in Figure Figure 7.23 Image enlargement screen o Press and drag LCD window without releasing, and move to desired area to confirm as shown in Figure Figure 7.24 Enlargement image move o To reduce enlarged image again, press image reduction button

34 Image reverse o To reverse image brightness to contrasting condition, press image reverse button and activate reversed image of brightness contrasted condition. Figure 7.25 Image reverse o If pressing image reverse button once more, it changes to original image. Image rotation o If image rotation button is pressed, rotated image in 90 counter clock-wise can be confirmed as shown in Figure Figure 7.26 Image rotation

35 Brightness adjustment scrollbar o By using brightness adjustment scrollbar on left upper part of image processing panel image brightness can be adjusted as shown in Figure Figure 7.27 Image brightness adjustment CAUTION The image processing generates a lot of load to the system, you must finish one operation before you start another one. Please note that he overloaded image processing could a Gamma value adjustment scrollbar o By using gamma value adjustment scrollbar located at left bottom part of image processing panel, image tone can be adjusted as shown in Figure Figure 7.28 Image gamma value adjustment

36 Image Initialization o If pressing RESET button located on left side center of image processing panel, adjusted image is converted to initial status. Adjusted image save o If image processing is started, save button on upper part of right side is activated as shown in Figure Press save button to save changed or adjusted image. o Name of saved image file is in combined form of original file name and date and time of saving point. o File name can be changed by using RENAME function after moving to image list panel. Image save button Figure 7.29 Image save button activation

37 7.5 Network connection Preparation before connection SAF-4000 provides wireless image transmission function. Before using corresponding function, preparation as followings is necessary. o Wireless sharer with built-in network functionality o HOST program (provided along with SAF-4000) AP(ACCESS POINT) connection In main screen or menu screen on left side, press connect button to move connect panel. Device LOCAL IP display window HOST IP input window Connection port display window AP list display window Network adjustment panel activation button Communication Status among Hosts Confirm Button Connection status with host confirmation button Network Enable or Disable Select Button AP selection connection Password input window AP list search button button Figure 7.30 Network connect panel and name of each part Select and connect desired AP by pressing network adjustment panel activation button (Follow each communication company or wireless sharer company connection method) o Above connection method is limited to first time use only. Thereafter, connection can be done through network connect panel. If connecting previously connected AP again, it can be connected within network connect panel

38 Execute HOST (SAF-MAN) program. o Select desired AP, and input SSID PASSWORD (If there is no password given, move to next sequence) o Connect to AP by pressing AP selection connection button If AP connection is complete, LOCAL IP of device as shown in Figure 7.30 appears on screen. If LOCAL IP is displayed normally, AP connection is complete HOST program connection Run SAF-MAN program, that is installed on notebook computers, using AP or sharer such as SAF Move image explorer window Display current LOCAL IP address Image receive server function On/Off Move image receive window Server On/Off status display Connected device number display Figure 7.31 HOST (SAF-MAN) program run and name of each part Figure 7.31 is the screen that appears when running HOST (SAF-MAN) program installed on desktop, notebook, and etc. View LOCAL IP address on program upper section of current computer, and confirm server status through server on/off status display

39 If HOST IP input window of SAF-4000 network connect panel is touched, number keypad is activated as shown in Figure Enter LOCAL IP address through number keypad shown on HOST program. Figure 7.32 HOST IP input screen If HOST IP address input is complete, close keypad using Enter key. If connected while running desktop or notebook PC program, network connection display is activated in purple color as shown in Figure If connection is not smooth after inputting HOST IP address correctly, and desktop or notebook computer HOST (SAF-MAN) program is running normally, try reconnecting through SET button on network connect panel, and confirm whether communication is smooth through PING button. Figure 7.33 HOST program and SAF-4000 connected status

40 To use again after terminating equipment, reconnect PC host program to network. In this case, if environment is the same as before, simply press SET button on SAF-4000 NETWORK CONNECT panel for network connection. For more detailed usage of HOST (SAF-MAN) program, refer to 7.8 HOST program. CHECK Be sure that SAF-4000 image wireless transmission function is connected to AP(Access Point), such as desktop or notebook computer or wireless sharer. Confirm such condition before using. 7.6 Environment setting CAUTION The blue signal indicating network connection on right upper in display does not mean intensity. Therefore, user must use wireless transfer function in a short distance from AP. To check intensity of AP connection, please press AP category search button in NETWORK CONNECT Panel and check antenna status Environment setting panel Press set up button from main menu or left side menu, screen as shown in Figure 7.34 is displayed. BMP type image save JPG type image save select button select button Camera automatic run DICOM type image save select button select button Radiograph image host automatic transmission select button Radiograph image screen automatic adjustment select button Sound effect use setting button Figure 7.34 Environment setting panel and name of each part Sensor standby time setting button Software auto Update button

41 7.6.2 Save image format SAF-4000 image can be saved as three types of file image. Images can be saved in BMP, JPG, and DICOM file types, and if corresponding buttons for BMP and JPG type files are selected, and DICOM type image save selection button are pressed, input field window is created as shown in Figure First tab for DICOM file information input window is to enter patient's ID, name, and gender on patient information window. Second tab of DICOM file information input window is comprised of institution information window as shown in Figure 7.36, enter X-RAY radiographed institution and medical doctor information. Third tab of DICOM file information input field window is an address window, and for entering patient or radiograph institution address. Fourth tap is a manufacturer information window, and for entering device manufacturer and device information. Figure 7.36 DICOM file information institution tab input window

42 CHECK SAF-4000 DICOM file save is possible only if X-RAY is radiographed. Photographed image by camera is saved in BMP or JPG format, and if DICOM is selected, JPG file type is used as default Environment setting Buttons Sensor waiting time setting button is used to set waiting time until detector or sensor receives X-RAY signal after connecting device to detector or sensor and pressing READY button in X-RAY panel. If X-RAY signal is not received in waiting period, it changes to STANDBY status automatically. Waiting time setting is from 5 sec. to 180 sec. by one second interval. When camera is connected, camera automatic run setting button function is used to display images on camera panel. In this case, D-CAM oral camera runs automatically regardless of corresponding function setting. Radiograph image screen automatic fit setting button is used to adjust image brought up from radiograph or file manager to fit LCD window. Setting button using sound effect is the function that selects whether to use each function sound or button sound Automatic Software Update SAF-4000 has an automatic software update function. Save the update file sourced from or official by request in USB interfaced storage device (USB flash memory etc.). The file name is SAF-4000_Update.exe.. Connect the relevant storage device to USB port at front of SAF-4000 main body. Press update button in setup panel and software will be updated automatically. The current software update status can be checked by No. starting as 200.XX at left upper part of main display of SAF

43 7.7 HOST (SAF-4000) program HOST program installation When using AP or sharer such as SAF-4000, install DDC_setup.exe that comes with SAF-4000 on desktop or notebook computer. Figure 7.37 Host program installation screen If DDC_setup.exe file is clicked, installation screen is activated as shown in Figure Click NEXT button to move to next phase. Figure 7.38 Installation path input window

44 Enter path in installation path input field as shown in Figure 7.38, and click on NEXT button. Basic path is C:\SAFARI CENTER. Figure 7.39 Start menu folder registration window As shown in Figure 7.39, designate folder name for registration. If folder registration is not needed, check on "Don t create a Start Menu folder" on bottom part of left side. If setting is complete, click on NEXT button to move to next level. Figure 7.40 Background screen icon creation confirm window

45 In background screen as shown in Figure 7.40, icon creation inquiry window is activated. If icon creation is not wanted, uncheck corresponding check box. Move to next phase by clicking on NEXT button. Figure 7.41 Setting confirm installation screen Setting detail as shown in Figure 7.41 is displayed, and if all items are confirmed, click INSTALL button to start installation Figure 7.41 Installation termination and program run screen As shown in Figure 7.42, installation completion is notified, and window asking whether to run program is activated. If program run is not wanted, uncheck "Run DEXCOWIN MANAGER" box

46 TOOLBAR Program run Run HOST (SAF-MAN) program. Initial run screen is as shown in Figure Menu Bar Figure 7.43 HOST(SAF-MAN) program run HOST program is largely divided into MENU BAR and TOOLBAR. Menu Bar file menu o Open: Bring up image to use. BMP, JPG, PNG, DCM, IMG, and RAW types of files can be used. o Save As: Save images. BMP, JPG, and PNG file types can be used. Menu Bar view menu o Show Toolbar: show or hide Toolbar on menu window. o Show Image Effect Dialog: show or hide image effect applied information. o File Browser Style: show file displaying type on image list window. Report: show information such as image file name, and size, item type, modified date, and etc. on image list window. Thumbnail: show image as preview style on image list window. Icon: show image as unique icon shape based on file type on explorer window. List: show image only in file type on image list window

47 Raw Image Loading Mode: image revision effect is applied when bring up RAW type file that is not revised. 1 Normal Equalization: revise image by adjusting overall image brightness, and etc. 2 Center Equalization: If brightness gap is large, based on medium brightness, revise image by adjusting brightness gap in medium brightness base. 3 Equalization+Gamma: revise image by applying gamma value that improves image tone to Normal Equalization. - Lens Auto Zoom to 100: When applying lens effect, it applies image size to original size automatically. - Show Grid Always (Selected): After selecting Grid, set range and enlarge to maintain grid. - Show Property: display image information that is brought up. Menu bar Tools menu o RM Server: Turn on / off Remote Server function. When turning off RM Server function, image cannot be received wirelessly. o Change Local Down Folder: change image receiving folder path. o Use Get Public IP (On Start): display public IP address on top menu if connected to internet or other. File Browser Style: type of file displaying on image list window. 1 Report: show information such as image file name and file size, item type, modified date and etc. 2 Thumbnail: show image in preview style on image list window. 3 Icon: show image in unique icon shape based on file type on explorer window. 4 List: show image list window by file type. Menu Bar Window menu o REMOTE SCREEN: navigate to Remote Screen window. o LOCAL DRIVE: navigate to Local Drive window. o DATA MANAGER: navigate to Data Manager window. Menu Bar Help menu o About: display Host (SAF-MAN) program. TOOLBAR menu o REMOTE SCREEN: navigate to Remote Screen panel. o LOCAL DRIVE: navigate to Local Drive panel. o DATA MANAGER: navigate to Data Manager panel. o RM Server: Turn on / off image receiving server function. Current status is displayed on Server part on right side at bottom of program

48 7.7.3 Program utilization HOST (SAF-MAN) program consists of two types of basic panel such as REMOTE SCREEN, and LOCAL DRIVE. Click on TOOLBAR REMOTE SCREEN part and move to corresponding panel. REMOTE SCREEN panel displays transmitted image from SAF-4000, and can carry out simple functions such as image enlargement and reduction, rotation, reverse effect, and etc. Figure 7.44 REMOTE SCREEN panel image receiving screen Name of each part of image processing tool is as shown in Figure Each function is as following. Save As Rotate (90ccw) Fit to Screen Draw Grid Edit Mode UNDO Path of Image Open Image Negative Effect Return to Mouse Resampling / Zoom 100% Interact to Auto Contrast Effect Size Moving Scroll 7.45 REMOTE SCREEN Image processing tool name

49 - UNDO: Cancel previously performed task. - Open Image: Bring up new images. - Save As: Save current working image or bring up image as other name, and only BMP, JPG, PNG formats can be saved. - Negative Effect: Carry out image brightness reverse function. - Rotate (90CCW): Rotate image to counter clock-wise Return to Zoom 100% Effect Size: Restore image to original size. - Fit to Screen: Display image height by adjusting to screen size. - Mouse Interact to Moving Scroll: Image is shown based on mouse pointer position. - Draw Grid: create grid pattern on screen. - Resampling / Auto Contrast: image re-sampling and automatic chroma adjustment function. - Edit Mode: move current image to LOCAL DRIVE panel. LOCAL DRIVE panel is comprised of file explorer window, navigator, and image effect adjustment window, and performs various functions such as various image conversion, angle, distance measurement, and etc. Drive explorer window Image Processing Toolbar Navigator Image list window Figure 7.46 LOCAL DRIVE panel image edit screen and name

50 - Drive Explorer Window: Navigate desired image saved folder in PC drive explorer window. - Image list window: show image type file list in designated folder of drive explorer. If file to edit is selected, corresponding image can be brought up to edit screen. List window can be changed by selecting view type from Menu bar (View File Browser Style). - Image processing Toolbar: show basic image processing task list. Name of each part for image processing Toolbar is shown in Figure 7.58, and function is as following Figure 7.47 Name of each part for image processing Toolbar 1 Un/Collapse Folder Window: show or hide drive explorer window. 2 Open History Image List: show previously processed image list. 3 Navigation Mode: show or hide Navigator. 4 Open Image: bring up new image. 5 Save As Image: save currently working image file. 6 Undo/Redo: cancel or restore last task of the image. 7 Return to Zoom 100% Effect Size: restore original image size. 8 Fit to Screen: display image height to fit screen size. 9 Mouse Interact Zoom/Drag: Mouse left side button - image enlargement, right side button - image reduction, drag- image move 10 Mouse Interact - Select: Zoom: Mouse left side button - image enlargement, right side button - image reduction 11 Lens (Hist-Equalization): show revised of image brightness and tone of lens effect applied area. 12 Mouse Interact Mode: Current mouse function display 13 Equalization Mode: display image revision item applied to current image 14 Equalization Tools: Total three types of revise function is provided. a. Hist-Equalization: revise image by adjusting overall image brightness and etc. b. Hist-Equalization+Gamma(0.5): revise image by applying gamma value 0.5 along with Hist-Equalization. c. Hist-Equalization+Gamma(0.75): revise image by applying gamma value 0.75 along with Hist-Equalization. 15 Draw Grid: create grid pattern on screen. 16 Show Image Property: display working image information

51 Navigator: display image activation area of edit window. If certain part of Navigator is clicked, edit screen moves to corresponding image area, and activation area of Navigator can be moved to other areas by dragging. For edit window, image is moved based on activation area. Image effect adjustment window: Image effect adjustment window includes functions such as image detail edit or subject distance and angle, and etc. Name of each part for image effect adjustment window is shown in Figure and function of each part is as following; 1. Image Reset: cancel all performed tasks and restore to original image 2. Zoom In: image enlargement button 3. Zoom Out: image reduction button 4. Undo: cancel recently performed task detail 5. Redo: restore cancelled task detail 6. Zoom Control Scroll Bar: image enlargement or reduction function scrollbar 7. Brightness Control Scroll Bar: brightness adjustment scrollbar 8. Contrast Control Scroll Bar: chroma adjustment scrollbar 9. Gamma Control Scroll Bar: gamma value adjustment scrollbar 10. Mouse Interaction/Drag: mouse function / image drag move mode 11. Mouse Interaction/Zoom: mouse function / image enlargement or reduction mode 12. Mouse Interaction/Lens: mouse function / lens effect mode 13. Mouse Interaction/Object: mouse function / object function 14. Measure Distance: distance measurement within designated distance measurement 15. Ruler Multi: designated distance dimension within image - multiple dimension express function 16. Line Arrow - Multi: designated arrow display within image - multiple arrow sign function, multiple section arrow display function, number display function when checking check box next to button 17. Angle Multi: angle display function between designated sections 18. Box Multi: box line display of designated diagonal line - display as semi-transparent face when checking check box next to button 19. Clear Objects: delete all object applied detail 20. Cancel Object: delete recently object applied detail 21. Normal/Select Mode: Normal - add new Object, Select - previous Object modification and move 22. Unit/Scale of Ruler: dimension unit modification, and scale change based on pixel size is possible 23. Line Color: Line and color change applied to object is possible 24. Font: font change 25. Line Style: line shape selection function - applied to arrow and box line only

52 26. Line Width: line thickness change is possible 27. Invert: image color reverse function 28. Flip Horizontal: left and right reverse function 29. Flip Vertical: top and bottom reverse function 30. Re-sampling Image: image revise repeat 31. Rotate (90 CCW): 90 rotation to counter clock-wise direction is possible 1-Image Reset 2-Zoom In 3-Zoom Out 4-Undo 5-Redo 6-Zoom Control Scroll Bar 7-Brightness Control Scroll Bar 8-Contrast Control Scroll Bar 10-Mouse Interaction/Drag 11-Mouse Interaction/Zoom 9-Gamma Control Scroll Bar 13-Mouse Interaction/Object 12-Mouse Interaction/Lens 15-Ruler - Multi 17-Angle - Multi 19-Clear Objects 22-Unit/Scale of Ruler 23-Line Color 25-Line Style 14-Measure Distance 16-Line Arrow - multi 18-Box - Multi 21-Normal/Select Mode 20-Cancel Object 24-Font 26-LineWidth 27-Invert 31-Rotate (90 CCW) 28-Flip Horizontal 29-Flip Vertical 30-Resampling Image Figure 7.48 Name of each part on Image effect adjustment window

53 7.8 Wired remote controller Wired remote controller usage Connect using wired remote controller connector to wired remote controller connection port on behind part of SAF-4000 device. If button is pressed after exposure range is adjusted, X-RAY exposure is performed. Wired remote controller performs only exposure function, other settings and operations can be manipulated through device LCD window. Figure 7.49 Wired remote controller connection

54 7.9 Battery Mounting battery inside Main body Check if SAF-4000 device power is OFF. As shown in Figure 7.50, battery pack cover should be separated by pulling the cover backward after pulling displayed circle part CHECK If residual quantity display is low on LCD window, replace it with extra battery pack. Power can be turned off automatically some time after battery is not replaced. Figure 7.50 Main battery cover separation When battery cover is separated, battery pack should be inserted to main body. As shown in Figure 7.51, battery pack should be pushed inside in the direction of arrow from side of main body. At this moment, the battery s label side should be backward of the main body and sticking out shape in battery's both ends should fit precisely with main body groove

55 Close battery cover. At this moment should be close by pressing it until the end of the cover is tightly combined with the main body and making a clicking sound. Turn power on to confirm if device is operating normally. Place label part to the main body s backside and insert it by adjusting it to the rail of the main body Direction of Insertion Figure 7.51 Main body battery pack insertion Battery level and charging SAF-4000 battery is a high output power and is designed to charge separately from main body for safety purpose. Battery charging period can be notified through beeping sound from LCD window or at power turning on. During operating, if battery replacement period is reached, LCD window of battery level will show LOW status, and device is not available for X-RAY exposure. Also, pop up window is activated to notify battery replacement. Battery level display and battery residual quantity shown on right side of LCD window is as shown in Figure If battery residual quantity is between 0 ~ 10% section, replace with charged battery. 0~10% 11~30% 31~55% 56~80% 81~100%

56 Battery charger consists of charger adapter and charging cradle. Charging cradle and adapter shape is shown in Connect charger adapter DC plug to charging jack of back side of charging cradle. Use bundled AC power line to connect charger adapter, and connect to AC power code. AC power voltage range and frequency is V AC / 50-60Hz. Be sure to confirm if it is rated power before connecting AC power. Figure 7.53 Battery cradle and charger adapter Place the battery on the charge cradle as picture 7.54, from upper to inside. At this moment should be place the charge cradle connector and battery connector at the same point, close them until the furrow of the charger cradle s backside is hooked with the furrow of the battery s backside. While charging battery, red LED is displayed on charger cradle, if charging is complete, green LED light is displayed on charging cradle. 2 Fit cradle connector and battery connector direction and settle from top 1 Connect charger DC plug to back side of jack on battery cradle 3 Start charging after precise settling Figure 7.54 Battery cradle and battery settling

57 8 Maintenance and storage method 8.1 Maintenance and storage Storage product or battery pack in safe place so people other than qualified personnel are being able to have access. X-RAY radiation field that contacts patient directly should be maintained cleanly by wiping often with rubbing alcohol soaked wiping clothes. Do not use near heater, heating device, and etc. For some digital sensors, keep the equipment clean since they are used to contact body directly. Also, be sure to keep them in storage cases after using. Do not convert randomly. If SEAL attached to product is damaged, free A/S is not provided. Use device and parts safely after performing regular checkup at designated A/S center only. Avoid following places for use of the device and storage. o Place with lots of moisture o Place with direct sunlight o Place with lots of dust o Place with high humidity o Place with no ventilation o Place with lots of saltiness o Place with chemical substance or explosive gas 8.2 Storage method Check for Product storage Avoid place with high humidity or direct sunlight when storaging. Avoid place with lots of dust, slope, and dirt when storaging. Do not store at extreme high or low temperatures. When not using for long time, store product separately after removing battery

58 8.2.2 Product Storage Digital sensor is very sensitive equipment and should be kept clean at all times. Avoid places exposed to shock or vibration, and keep in storage case. Digital sensor provided separately in extra case, while not using, keep it in corresponding case Charger and cradle storage Take caution not to have foreign substance at cradle charge terminal, and wipe gently using cotton rod and soft clothes before storaging. While not using the product, store after gently wiping. Take caution for battery pack (charger) not to contact with metallic substance (coin, key, clip, and etc.). Do not mount other company brand battery on charger for use. 8.3 Items To Check Daily Inspection Items When turning on product power, confirm if power on sound goes off, and normal initial screen is displayed. If exposure time setting are changed by using manipulation button, confirm if time is changed normally. When digital sensor is connected with main body, confirm if it is recognized normally. When performing X-RAY exposure, confirm if beeping sound goes off, and exposure button turns to yellow. When charging battery pack, check LED light of cradle to confirm normal operation

59 8.3.2 Monthly Inspection Items Confirm if battery pack use period is proper. Purchase new battery pack if use time of initial use is reduced in half. CHECK Battery pack is consumables, and use time is reduced gradually compared with purchasing time. If use time is shortened to more than half compared with first use frequency time, replace with new battery pack Yearly inspection items For safe use of product, perform product correction and safety inspection annually. Contact Safari Dental Inc. with inquiries related to product correction and safety inspection

60 9 Inspection items before repair request 9.1 Confirm items before requesting inspection If abnormality is found in product, confirm following items before inspection request. Symptom Steps to take After turning on power, both sound or LCD screen are not turned on Confirm battery is mounted correctly and replace with charged battery. If not using product for a long time, separate battery from product to prevent battery discharging Power defect LCD screen is not displaying after power on sound is heard While system is booted, LCD screen may not be displayed for a while. Wait until product UI is displayed by PC booting completion after passing SAFARI logo. If screen is not displayed after a few minutes, contact designated A/S center. While using (including X- RAY exposure), if power turns off automatically Check battery residual quantity. This product supports automatic power turn off function to reduce battery consumption. Be sure to set exposure setting value before X-RAY exposure, and press READY button for exposure. Exposure defect When X-RAY is working for exposure, and exposure sound does not go off Confirm battery residual quantity, and replace with charged battery. X-RAY exposure may not be performed if battery level is low. Check if PC is connected through USB cable normally and separate the USB cable. Check if the panel of LCD display is X-RAY mode. X- RAY exposures only with X-RAY panel

61 Radiograph image problem Symptom After image is radiographed using sensor, if image of LCD screen is shown enlarged or reduced After image is radiographed using sensor, if LCD screen image is too blurred or too dark Radiographed image is not showing after image is radiographed using sensor Why are there spots showing on radiographed image using sensor? Low battery sign is displayed on LCD window Steps to take Check if image display is set to display fitting to LCD screen in environment setting. In case of digital sensor, image can be viewed with 1/10 of X-RAY used existing film. Perform radiograph again after adjusting to proper time. Confirm if sensor is connected to product. if sensor is not connected, radiograph image may not be displayed or noisy image many be displayed. If image is not radiographed even after sensor is connected, contact designated A/S center. Confirm if sensor is connected to product accurately. If image does not have any change after taking measures, contact designated A/S center. Check battery pack residual quantity, and replace with charged battery pack. Confirm if battery pack cover is closed, and if it is open, check battery connection and close it by pushing cover all the way. Others Confirm LED of battery charger adapter and cradle. When battery is not charged If LED of battery charging cradle is red while charging, charged status is displayed in green only. Confirm if battery charging cradle and battery pack are connected accurately

62 10 Product specification and quality assurance 10.1 Product Specification Classification Product name Grade Input Power B-type mounting Waterproof Rating Fireproof Mode of operation Tube voltage Tube current Focal spot size Voltage consumption Voltage Usage Battery Pack Cooling method Total Filtration Target Angle Time setting Distance to target X-RAY field Size of main body Weight of body Details Digital X-RAY radiograph device Class Ⅱb (MDD 93/42/EEC as amended by 2007/47/EC) Use the internal power supply (Battery) Cone IPX0 (General Equipment) This equipment is not suitable for use in the presence of flammable anesthetics or oxygen Continuous operation 60kV (Fixed) 2mA (Fixed) 0.8mm 240W (MAX.) DC 15V Lithium-polymer 4Cell 1050mAh Large Capacity Battery Pack Oil Cooling Method More than 2.3mmAl (Inherent Filtration: 0.8mmAl, Fixed added filter: 1.5mmAl) ~ 1.35[sec] (Unit: 0.01sec) Distance between target and Focal Spot > 20cm (Fixed by cone) 50mm Round style 240(L)x166(W)x82(H) 2.6kg (Include Battery)

63 11 SAF-4000 Technical document 11.1 High voltage generator X-RAY Tube 1. Manufacturer : TOSHIBA 2. Model : D-081B 3. Electrical Characteristics i. Operating Tube Voltage 65kV ii. Focal Spot 0.8 mm iii. Input Power (at 1.0s) 600W 4. Mechanical Characteristics i. Dimensions ii. Target angle 20 Degrees iii. Material Tungsten iv. Inherent Filtration At least 0.8 mmal equivalent at 50kV

64 5. Anode Thermal Characteristics 6. Absolute Maximum and Minimum Ratings i. Maximum Tube Voltage 65 kv ii. Maximum Tube Current 19mA iii. Maximum Filament Current 2.0 A

65 11.2 Electromagnetic compatibility SAF-4000 has been tested and found to comply with the limits for medical devices in IEC/EN These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to other devices in the vicinity. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to other devices, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: Reorient or relocate the receiving device. Increase the separation between the equipment. Consult the manufacturer or field service technician for help Radiation protection SAF-4000 IEC , IEC , IEC from regulatory limits on radiation safety and protection compliant. X-RAY operator must protect him/herself with a lead apron or wall. Must provide a patient protecting materials, such as a lead apron while operating. Must operate only inside the X-RAY protecting facility. X-RAY operator must pay attention on the status of a patient to provide for emergency. X-RAY operator must stop operating if there s any disorder is detected. A pregnant woman and children must be advised for X-RAY operation

66 11.4 Product Label Use DC Battery power source. 2. B type mounting part: The parts which are intended to install with a patient are qualified with the protection regarding electric shock and leakage current tolerance. 3. This sign indicates that electronic product should not be thrown away as regular garbage or recyclables. It may be dangerous to discard this product without treatment. Please contact with retailer or waste treatment company. 4. Caution notation and refer the user manual 5. Manufacturer notation 6. Manufacture date notation 7. Product number notation