OsteoSys SONOST 3000 User Manual
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OsteoSys SONOST 3000 User Manual

Bone densitometer
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See also: User Manual
SONOST 3000
User's Manual
Model: SONOST 3000
Council Directive 93/42/EEC Concerning Medical Device
http://www.osteosys.com
OsteoSys Co., Ltd.

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Summary of Contents for OsteoSys SONOST 3000

  • Page 1 SONOST 3000 User’s Manual Model: SONOST 3000 Council Directive 93/42/EEC Concerning Medical Device http://www.osteosys.com OsteoSys Co., Ltd.
  • Page 2 User’s Manual Software Version : 3.03.06 Document Version : 4.00 Document Number : OT06-2R0422-00-MUL Manufacturer and EC Authorized Representative Information ♣ Manufacturer : OsteoSys Co., Ltd. 3F, 308, Byucksan Digital Valley3 , 212-13, Guro-Dong, Guro-Gu, 152-848, Seoul, Korea Tel : 82-2-2025-1650 Fax : 82-2-2025-2299 ♣...
  • Page 3 OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R0422-00-MUL Thank you for purchasing SONOST 3000 Ultrasound Bone Densitometer. To ensure safe operation and long-term performance stability, it is essential that you fully understand the functions and operating, maintenance instructions by reading this manual before operating the equipment.
  • Page 4 OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R0422-00-MUL The symbols which are shown in this manual or SONOST 3000 The noticed information which should be concerned with explanation in this manual The noticed information when the device is operated...

  • Page 5: Table Of Contents

    3.2.7 Calibration of SONOST 3000(DailyTest) ..........3 4 3.2.8 Printing of clinical history and Result ..........3 6 Chapter 4. Maintenance and Repair of SONOST 3000 ........... 3 8 4.1 Resolution to Problems ................... 3 8 4.2 Maintenance and Repair ................3 9 4.2.1 Cleaning, Disinfection, Sterilization ............
  • Page 6 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R0422-00-MUL 5.1 Specifications ....................4 7 5.2 Software Updates .................... 4 9 Chapter 6. Reference ....................5 0 6.1 Definition of Parameter Terminology ............5 0 6.2 Reference Data ....................5 2 Chapter 7 .

  • Page 7: Chapter 1. Introduction

    User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R0422-00-MUL Chapter 1. Introduction Osteoporosis is one of the serious diseases. This device is a bone densitometer which estimates a bone mineral density of the calcaneus by ultrasound.
  • Page 8 The equipment must be operated only by, or under supervision of a qualified person. When you give the appropriate commands in SONOST 3000 software, ultrasonic waves are generated. The generated ultrasonic waves pass through the Patient’s calcaneus and the electric signal is treated by SONOST 3000 algorithm.

  • Page 9: Chapter 2. Configuration Of Device

    User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R0422-00-MUL Chapter 2. Configuration of Device 2.1 Composition of Device 2.1.1 Shape and Components of Device Name Function 1-1 TOP COVER Protection for internal circuit 1-2 CALF SUPPORT...

  • Page 10: Accessories List

    NOTE ! Use Accessory which defined at user‘s manual. 2.1.2 Accessories List Check the following accessories before installing the system. If they are not in good condition, contact to OsteoSys or its authorized dealer for this service. Names of Number...

  • Page 11: Articles List

    DOC. No. : OT06-2R0422-00-MUL 2.1.3 Articles List Check the following accessories before installing the system. If they are not in good condition, contact to OsteoSys or its authorized dealer for this service 4.2.2 Stockpiles and Replacement of Articles Names of Products...

  • Page 12: Installation Of Sonost 3000

    User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R0422-00-MUL 2.2 Installation of SONOST 3000 NOTE ! Since SONOST3000 is made up of precise components, you should install the product according to instructions below. Do not install and keep SONOST3000 at Do not install or keep SONOST3000 in excessively high or low temperatures.

  • Page 13: Before Turning On Power

     If you find any damage or any sign of it, immediately contact an agency.  Put the Power cord into only one plug  Make sure not to share the power outlet to prevent SONOST 3000 from being affected. １３ A4(210 × 297) OT00-2F0423-01...

  • Page 14: Chapter 3. Using Sonost 3000

    User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R0422-00-MUL Chapter 3. Using SONOST 3000 3.1 Using H/W 3.1.1 Patient Measurement Procedure Clean the surface of the Coupling Pad with an alcohol and apply gel enough.

  • Page 15: Where And How Much Apply To The Patient's Heel

    User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R0422-00-MUL NOTE ! Insert patient’s foot after widen probe’s gap enough, because probe pad is made from soft silicon. 3.1.2 Where and How Much Apply to the Patient’s Heel Before measuring, using alcohol to rub patient’s heel :...

  • Page 16: Correct Position For Patient's Foot & Body

    User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R0422-00-MUL 3.1.3 Correct position for Patient’s foot & body Adhere a heel to the measuring device closely as shown 3 points below. Make sure measuring device and body should be one line as shown below.

  • Page 17: Setting Of Internal Printer

    User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R0422-00-MUL 3.1.4 Setting of Internal Printer  Paper type : Thermal paper width 58mm. thickness : MIN 0.07mm (About 80 reports are printable by one roll)  Paper character : Only printable in an outer surface ...
  • Page 18 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R0422-00-MUL ③ Cover shutting : Put the paper to the gap in the cover, then shut the cover ⑥ Paper cutting : For a sharp outline of report printing, cut off the remained paper once by a saw tooth in the cover.

  • Page 19: Using S

    User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R0422-00-MUL 3.2 Using S/W 3.2.1 Progress Table of Program Dailytest Start Setup Home Product Information Add Patient Patient List Measure Search Patient Start Measure Modify Patient History List...

  • Page 20: Execution Of Program

    User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R0422-00-MUL 3.2.2 Execution of Program CAUTION ! If you hear any strange noise from the screen, switch it off and contact to OsteoSys or its Authorized dealer.

  • Page 21: Setting Of The Incipient Environment

    User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R0422-00-MUL 3.2.3 Setting of the Incipient Environment Click the <Setup>button on the Home Screen, then environment window is appeared. Setup Window - <Settings> : Fundamental settings related Software.
  • Page 22 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R0422-00-MUL - Hospital Name : Insert the hospital name which will be on the report. - Default Scan Site : Select the default scan site when measure.
  • Page 23 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R0422-00-MUL  Cleaning It makes probe is moved of user’s own accord for cleaning. Setup>Cleaning Window - Narrow : It makes narrow the probe’s interval - Stop : It makes the probe stop.
  • Page 24 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R0422-00-MUL Setup>Backup>Export Window All : Export all data. By period : Export data within a selected period of time. Individual : Export selected patient’s data. * Destination : You can select USB Memory Stick or Printer.
  • Page 25 At first, Prepare a USB removable disk which support USB 1.1. You can use mp3 player or digital camera too. Copy the patch file(file name : NK.BIN) to USB removable disk. Insert USB removable disk into SONOST 3000 device’s USB port. ２５ A4(210 × 297)
  • Page 26 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R0422-00-MUL Click File open button And select the patch file. (Generally, USB removable disk is “Hard Disk2” folder) Click Patch button. Cursor is changed to a sandglass. Patch takes 5-10 minutes.

  • Page 27: Measurement Of Bone Mineral Density(Bmd Measurement)

    User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R0422-00-MUL 3.2.4 Measurement of Bone Mineral Density (BMD Measurement)  Patient Registration and Search If you click the <patient>button on the top line at the incipient screen, you can move to “Patient List”...
  • Page 28 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R0422-00-MUL (64 characters are MAX) Name : Insert the patient’s name. (64 characters are MAX) Year of Birth : Insert the patient’s year of birth. Gender : Insert the patient’s gender.
  • Page 29 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R0422-00-MUL  Measurement of Patients If you want to measure the patient’s Bone Density, select a desired patient in the Patient List screen and click the <Measure>button. Then the “Measure”...
  • Page 30 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R0422-00-MUL about 15 seconds after, then the “Measure Complete” window is appeared with the alarm sound. If you click the <Ok> button, the detailed results is displayed as shown below.

  • Page 31: Revision And Deletion Of Patient's Information

    User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R0422-00-MUL 3.2.5 Revision and Deletion of Patient’s Information  Revision of Patient’s Information If you want to revise the registered patients’ information, select a desired patient and click the <Modify>button on the bottom.

  • Page 32: Inquiry And Deletion Of Clinical History Of Existing Patients

    User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R0422-00-MUL 3.2.6 Inquiry and Deletion of Clinical History of Existing Patients  Inquiry of Clinical History of Existing Patients If you want to retrieve the clinical history of existing patients, select a desired patient and click the <History>button on the top of the “Patient List”...
  • Page 33 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R0422-00-MUL  Deletion of Clinical History of Existing Patients If you want to delete the clinical result of patients, select a desired result and click the <Delete>button on the bottom of the result screen. Then the message box “Delete History?”...

  • Page 34: Calibration Of Sonost 3000(Dailytest)

    OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R0422-00-MUL 3.2.7 Calibration of SONOST 3000(DailyTest)  DailyTest Make sure to calibrate the system to reduce a margin of error and to get accurate value in times of examining bone density. It is to raise credibility of examination results through checking of system reliability on a daily basis.
  • Page 35 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R0422-00-MUL NOTE ! In case of the screen shows the calibration has failed, do not use the system and execute “DailyTest” once again. If calibration fails continually, contact to OsteoSys or its authorized dealer.

  • Page 36: Printing Of Clinical History And Result

    Inner printer is affixed on the device back inside. It will be able to use without software setting. Printed result paper  External Printer (Normal Printer) SONOST 3000 use a general USB support printer as external printer. It is required to setup printer in detail, because a kind of external printer various. ３６...
  • Page 37 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R0422-00-MUL - Printer : Selection of printer. - Port : Selection of port. (Must select LPT1.) - Paper Size : Selection of paper size. - Draft Mode : Selection of print quality (Checked : Low Quality, No...

  • Page 38: Resolution To Problems

    Is the desired part of the body properly Despite measurement according placed? to the instructions, its result 4.2.1. Cleaning, Disinfection, turns out to be abnormal Sterilization CAUTION ! If you cannot resolve the problem, contact to OsteoSys or its authorized dealer. ３８ A4(210 × 297) OT00-2F0423-01...

  • Page 39: Maintenance And Repair

    User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R0422-00-MUL 4.2 Maintenance and Repair 4.2.1 Cleaning, Disinfection, Sterilization. CAUTION ! Turn off the power before cleaning the device. Product Instructions After using the device, wash with water.

  • Page 40: Stockpile And Replacement Of Articles

    - Unplug the power cord. - Put cover on the product to avoid dust. Storage - Keep the product according to instructions described in “2.2 for a Installation of SONOST 3000” long time period 2.2 Installation of SONOST 3000 ４０ A4(210 × 297) OT00-2F0423-01...

  • Page 41: Safe Use Of Sonost 3000

    OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R0422-00-MUL 4.3 Safe Use of SONOST 3000 4.3.1 Safety Rules The followings are instructions for safe use of the product Make sure to comply with the instructions when you activate the system.

  • Page 42: Cautions Related To Use Electronic Medical Equipment

    １ Nobody can handle SONOST 3000 except for doctors and authorized personnel ２ Comply with followings in times of installation of SONOST 3000. Do not install it in following places. A) Places where the product is exposed to water vapor B) Places where the product is exposed to spray or splashing water.
  • Page 43 OsteoSys or its authorized dealer for assistance. G) Before electrically or mechanically connection any other manufactures’ devices to SONOST 3000, contact OsteoSys or its authorized dealer for instructions H) Do not operate the product improperly when you use it with other products.
  • Page 44 Otherwise, abnormal images may result. An independent circuit and a safely grounded outlets are strongly recommended for SONOST 3000. Poor or abnormal images may occur if the system shares a power source with other electrical or electronic equipment.
  • Page 45 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R0422-00-MUL D) If the fuses are gone, exchange the same type (250V T315AL). Otherwise a fire may occur or you may receive electric shock. NOTE ! Fuse Replacement 1.Open the fuse drawer on the upper side of the appliance inlet, there will be...
  • Page 46 E) Make sure to clean the product so that users can use it immediately ６ If the product is out of order, do not try to repair it for yourself. ７ Do not modify use the product. If any modification is desired, ask OsteoSys or its authorized dealer for this service.

  • Page 47: Chapter 5. Specifications & Software Updates

    User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R0422-00-MUL Chapter 5. Specifications & Software Updates 5.1 Specifications *General Ⅰ Classification Class , Type BF Applied part *Device 615mm × 293mm × 310mm Dimensions 12Kg Weight...
  • Page 48 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R0422-00-MUL *Environmental 10 ~ 40℃ Operating Temperature Transport / Storage Temperature -10 ~ 70℃ 30 ~ 75% relative humidity Operating Humidity Transport / Storage Humidity 0 ~ 90% relative humidity, non-condensing...

  • Page 49: Software Updates

    OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R0422-00-MUL 5.2 Software Updates 1. Updates to SONOST 3000 software are available at our homepage (http://www.osteosys.com). 2. Updates to SONOST 3000 software are free, regardless of the product warranty. 3. Updates to SONOST 3000 software are irregular, we will inform you through your email whenever SONOST 3000 software needs to be updated.

  • Page 50: Chapter 6. Reference

    User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R0422-00-MUL Chapter 6. Reference 6.1 Definition of Parameter Terminology  BUA(Broadband Ultrasound Attenuation) Parameter which reflect bone density and structure by reduction analysis of ultrasound pulse intensity which through the bone.
  • Page 51 User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R0422-00-MUL 3) T < -4, T > +4 : 6.3 of 10,000 persons 4) T < -3, T > +3 : 2.7 of 1,000 persons 5) T < -2, T > +2 : 4.6 of 100 persons For example, Person in T<-3 exist 1.35 ratio of 1,000 persons in whole...

  • Page 52: Reference Data

    User’s Manual (Confidential) OsteoSys Co., Ltd. Model Designation: SONOST 3000 DOC. No. : OT06-2R0422-00-MUL 6.2 Reference Data  Reference Data We achieved reference data from several group with different environment in Korea. And the data is analyzed by statistical method.

  • Page 53: Chapter 7 . Product Warranty

    (4) Cosmetic defects or deterioration will not be refinished or replaced. The costs of replacement of fuses are not covered. (5) OsteoSys Co., Ltd. will not be responsible for any loss, damage, or injury resulting from delay in rendering service under this warranty.
  • Page 54 OsteoSys Co., Ltd. will replace the defective product at no cost to you. OsteoSys Co., Ltd. will pay the shipping and insurance costs of product sent to you.

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