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Jawon Medical EX plus 1300 Owner's Manual

Automatic blood pressure monitor
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Summary of Contents for Jawon Medical EX plus 1300

  • Page 2 The device bears the CE label in accordance with the provisions of Medical Device Directive 93/42/EEC. THE PERSONS RESPONSIBLE FOR PLACING DEVICES ON THE EC MARKET UNDER MDD 93/42/EEC Jawon Medical Co.,Ltd. 29, Gongdan 4-ro, Jillyang-eup, Gyeongsan-si, Gyeongsangbuk-do, 38470, Republic of Korea TEL: 82-53-856-0993, FAX: 82-53-856-0995 VITAKO Sp.

  • Page 3: Table Of Contents

    TABLE OF CONTENTS • INTRODUCTION........................1. INDICATIONS ......................... 2. WORD DEFINITIONS...................... 3. CLASSIFICATION AND COMPLIANCE................4. SAFETY PRECAUTIONS....................5. SAFETY SYMBOLS AND INFORMATION..............6. Guidance for Electromagnetic compatibility(EMC)……………………………….. • TERMS OF EACH PART AND FUNCTIONS............... 1. FRONT PART........................2. REAR PART........................… 3.
  • Page 4 1. AFTER SERVICE......................2. PACKING AND TRANSPORT..................• SPECIFICATION......................... • WARRANTY........................

  • Page 5: Introduction

    1. INDICATIONS Indications for use The EX PLUS 1300 is intended to measure systolic and diastolic blood pressure and pulse rate in adults with an arm circumference of 22-33 cm. The EX PLUS 1300 is intended for use in physicians‟ offices, hospitals, clinics and other medical facilities where non-invasive blood pressure is performed on patients and invasive measurement is contraindicated.

  • Page 6: Classification And Compliance

    3. CLASSIFICATION AND COMPLIANCE 1) This device is classified as; - Class 1 type-BF against electric shock - Ordinary equipment without protection against ingress of water - Equipment not suitable for use in presence of a flammable anesthetic mixture by standard of EN 60601-1:2006(Safety of Medical Electrical Equipment) 2) This device is complied with Class A for Noise-Emission, Level B for Noise-immunity, by standard of IEC 60601-1-2:2007(Electromagnetic Compatibility Requirements).
  • Page 7 - Where the unit is exposed to dust. - Where the unit is exposed to water vapor. - Where the unit is exposed to salty atmosphere. - Where the unit is exposed to explosive gas. - Where the unit is exposed to excessive shocks or vibrations. - Where the angle of inclination of mounting surface exceeds 10 degrees.
  • Page 8 This manual is made for informational purpose and this manual and product Caution are not meant to be a substitute for the advice provided by your own physician or other medical problem. You should not use the information contained in the product for diagnosis or treatment of health problem or prescription of medication by yourself.

  • Page 9: Safety Symbols And Information

    5. SAFETY SYMBOLS AND INFORMATION The International Electrotechnical Commission (IEC) has established a set of symbols for medical electrical equipment which classifies a connection or warning of any potential hazard. The classifications and symbols are shown below. Save these instructions for your safety. Degree of protection against electric shock: TYPE BF Please observe operating instructions General warning sign...
  • Page 10 "ON" (only for a part of equipment) This symbol is used inside system. Identifies the point where the safety ground of the system is fastened to the chassis. Do not open. This is for factory only. Alternating current Direct current Date of manufacture Manufacturer Non-ionizing radiation...
  • Page 11 Foot switch Start or stop the measurement. And, when your arm is oppressed due to high pressurizing or irregular operation is done, press this button then the cuff will be exhausted rapidly. Hand-held switch Start or stop the measurement. And, when your arm is oppressed due to high pressurizing or irregular operation is done, press this button then the cuff will be exhausted rapidly.

  • Page 12: Guidance For Electromagnetic Compatibility(Emc)

    1) Guidance and manufacturer’s declaration – electromagnetic emissions The EX PLUS 1300 is intended for use in the electromagnetic environment specified below. The customer or the user of the EX PLUS 1300 should assure that it is used in such an environment. Electromagnetic environment – guidance...
  • Page 13 3) Guidance and manufacturer’s declaration – electromagnetic immunity 2 The EX PLUS 1300 is intended for use in the electromagnetic environment specified below. The customer or the user of the EX PLUS 1300 should assure that it is used in such an environment. Compliance...
  • Page 14 To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the EX PLUS 1300 is used exceeds the applicable RF compliance level above, the EX PLUS 1300 should be observed to verify normal operation.
  • Page 15 4) Recommended separation distances between portable and mobile RF communications equipment and the EX PLUS 1300 The EX PLUS 1300 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the EX PLUS 1300 can help prevent...

  • Page 16: Terms Of Each Part And Functions

    TERMS OF EACH PART AND FUNCTIONS 1. FRONT PART ① START / STOP BUTTON Press „Start‟ to start the measurement. The cuff starts winding up automatically and begins to pressurize. Press the button to stop the measurement. Pressurization will stop and the air will be exhausted from the cuff.
  • Page 17 FRONT PART ② INFORMATION BOARD ⑧ ARM REST ④ CLOCK SECTION ③ LCD DISPLAY ⑨ HUMAN SENSOR ⑦ CUFF ⑤PRINTER COVER ⑩ EMERGENCY STOP BUTTON ⑥ AUTOMATIC CUTTER ①START/STOP BUTTON ⑫ HAND SWITCH ⑪ ⑬ HAND SWITCH REST PEDAL SWITCH The side part of cart The under part of cart...

  • Page 18: Rear Part

    2. REAR PART ① POWER It turns the power on and off. ② POWER INPUT It connects the adapter. ③ R-CAL It is only for the inspection. Do not open it. ④ L-CAL It is only for the inspection. Do not open it. ⑤...
  • Page 19 REAR PART ⑪ INFORMATION BOARD FIXER ⑧ USB PORT (A TYPE) ⑩ HAND BUTTON PORT ③ R-CAL ⑤ EARTH ① POWER ⑨ PEDAL BUTTON ④ L-CAL PORT ⑦ USB PORT ② POWER INPUT (B TYPE) ⑥ COMMUNICATION PORT Note The operator should not touch both USB port and the patient‟s body simultaneously.

  • Page 20: Accessories

    3. ACCESSORIES Adapter/Power cable User Manual Information board PEDAL /HAND SWITCH Thermal paper / ROLLER Cart 4. OPTIONS Chair A4 RESULT SHEET...

  • Page 21: Installation

    INSTALLATION 1. CONNECTING ADAPTER Connect the adaptor to the power input on the back of the device. Turn on the POWER switch. Caution In order to avoid the risk of electrical shock, connect this device only to the power supply equipped with the protective grounding. Caution When connecting adaptor, place the arrow mark of adaptor connection part up and correctly stick it in the socket on the rear...

  • Page 22: Loading The Print Paper

    2. LOADING THE PRINT PAPER ① Pull the Top button up. Then press the Side button. Open the upper printer cover. ② Put the roller into the center hole of the thermal paper. ③ Insert the thermal paper with the roller into the holder as shown in the picture. ④...

  • Page 23: Connecting Ports

    3. CONNECTING COMMUNICATION PORT To transmit the data, connect EX PLUS 1300 to a computer or other external devices. Insert USB cable to the communication port and connect it to the computer as shown in the picture below. 4. CONNECTING PRINTER (Option) Connect A4 printer for the output in A4 size.

  • Page 24: Connecting Pedal Switch

    5. CONNECTING PEDAL SWITCH Connect the PEDAL SWITCH as shown in the picture. 6. CONNECTING HAND SWITCH Connect the PEDAL SWITCH as shown in the picture.

  • Page 25: System Setup

    SYSTEM SETUP Set the operating conditions for EX PLUS 1300. 1. Entering SYSTEM SETUP At the initial screen, press „Power' button on the left upper corner for 4~5seconds. Popup screen appears as shown in the picture. Press „1->2->3->4‟ to enter SYSTEM SETUP.

  • Page 26: Setup

    6. Setup <DATE TYPE> Set the Date Format. - Pre-set: YY-MM-DD (Year-Month-Day) - Select „Date type‟. - Press „SET‟ to save the change. - Press „CLOSE‟ and get back to SYSTEM SETUP menu. < DATE/TIME > Set the current time and the date. - Pre-set: The date released from the factory.
  • Page 27 <THERMAL PRINT> Choose the print option and set the result sheet form. - Pre-set: ON - Select „THERMAL PRINT‟ and enter the menu. - ON: Result sheet is printed after the measurement. OFF: Result sheet is not printed after the measurement. - Press „RESULT SHEET FORM‟...
  • Page 28 < PERSONAL DATA INPUT > It allows the user to input personal data. - Select „PERSONAL DATA INPUT‟ and enter the menu. - Select either „ON‟ or „OFF‟ for ID. - Select either „ON‟ or „OFF‟ for HEIGHT/WEIGHT INPUT. - Press „SET‟ to save the change. - Press „CLOSE‟...
  • Page 29 < PRINT POSITION > It adjusts the printing position in the direction of U-D (up- down) and L-R (left-right) to fit to the pre-formatted result sheet. - Select „PRINT POSITION‟ and enter the menu. - Pre-set: 00 for U-D and 00 for L-R - Range: 99 for U-D and 99 for L-R - Choose U-D by pressing „▼, ▲‟...

  • Page 30: Measurement

    ⑥ When you roll up the sleeves, make sure that the rolled up sleeves are not pressing the upper arms. ⑦ When the pulse is running too week and hard to be heard from stethoscope, EX PLUS 1300 can not make a measurement.

  • Page 31: Measurement

    2. MEASUREMENT *There are 3 ways to measure blood pressure. 1) Measuring method by using a foot switch. (Measure blood pressure on both arms simultaneously.) ① Plug the cable and turn on the power. ② As the power is on, the message appears as shown in the picture.
  • Page 32 ⑤ Pressurization starts automatically from the cuff and LCD indicates the current status. ⑥ When the measurement is completed, LCD screen displays the results. At the same time, voice guidance speaks out, “Measurement completed, pull your arm out please. Thank you.” The cuff deflates and turns to the initial state.
  • Page 33 ⑩ When you want to measure one more time, press button. The whole procedure restarts again. 2) Measuring method by using a hand switch. (Measure blood pressure on both arms simultaneously.) ① Plug the cable and turn on the power. ②...

  • Page 34: Result Sheet

    ⑤ When the measurement is completed, LCD screen displays the results. At the same time, voice guidance speaks out, “Measurement completed, pull your arm out please. Thank you.” The cuff deflates and turns to the initial state. 3. Result sheet ▼...

  • Page 35: The Measuring Method If Id Is On

    ▼Classification of the blood pressure : National High Blood Pressure Education Program, National Heart, Lung and Blood institute, NIH (JNC7, 2003) 4. Measuring method with ID Enter SYSTEM SETUP. From „PERSONAL DATA INPUT‟, activate ID use. ① Input data ID: On the initial display, press „ID‟. Enter ID using the number buttons.
  • Page 36 ② Measurement After entering the personal data, press „START‟. Pressurization starts automatically from the cuff and LCD indicates the current status. ③ Result When the measurement is completed, the user‟s ID, weight, height, Body Mass Index (B.M.I) and fatness are displayed as shown in the picture.

  • Page 37: The Measuring Method By Using „Three Measurement Mode

    5. The measuring method by ‘THREE MEASUREMENT MODE’. It measures blood pressure 3 times in a row. The average blood pressure from the three measurements indicates the more accurate data. It is possible to measure either one arm or both arms. System setup ->...
  • Page 38 ② Result After the third measurements, the average blood pressure is indicates as follows.

  • Page 39: Maintenance

    MAINTENANCE 1) Pay attention to allowable current value of power. 2) Avoid direct sunlight, humidity, dust, thick oil and salty or extreme changes in temperature. 3) Do not install or store this device in some space where any chemicals or gas is stored. 4) Do not use this device in any unstable, vibrating, or impact-giving area.

  • Page 40: Error & Repair

    ERROR & REPAIR Error Cause Repair ERROR PRESSURE pressure is high with the When message jammed air hose repeated, call maintenance service. ERROR CUFF pressure is low as air leaks When message repeated, call maintenance service. - Don‟t move or speak. ERROR MEASURE subject moves or speaks while in testing...

  • Page 41: After Service

    To ensure the device‟s proper and sage operation, please contact our company or distributor periodically for calibration. How to contact our company Write us at: Jawon Medical Co.,Ltd. 29, Gongdan 4-ro, Jillyang-eup, Gyeongsan-si, Gyeongsangbuk-do, 38470, Republic of Korea TEL: 82-53-856-0993, FAX: 82-53-856-0995 (You can also contact the following representative or your local distributor) 2.

  • Page 42: Specification

    SPECIFICATION Model EX PLUS 1300 Measuring Method Oscillometric Display mode Color LCD Touch display (7inch) Measuring one arm: Systolic Blood Pressure, Diastolic Blood Pressure Mean Blood Pressure, Pulse, Pulse Wave Pattern, Evaluation of Blood Pressure Result Contents Measuring both arms:...

  • Page 43: Warranty

    WARRANTY WARRANTY Item Automatic Blood Pressure Monitor Warranty period Model EX PLUS 1300 1year (main unit only) Serial NO. Date of purchase Month Year Name: TEL: Customer Address: Name: TEL: Dealer Address: Date Defection Confirmation Note - When you receive this warranty, make sure that the name of the dealer and the month, day and year of purchase are all completed.
  • Page 44 Pass/Fail 4 Measurement Proper measurement Pass/Fail General Judgment Pass/Fail Model EX PLUS 1300 Serial No. Installation place Date of purchase Check date Checked by Approved by Copy this sheet for use If repair is required, write down so in the Remarks column.
  • Page 45 Pass/Fail Other 1 Clock Present date/time Pass/Fail General Judgment Pass/Fail Model EX PLUS 1300 Serial No. Installation place Date of purchase Check date Checked by Approved by Copy this sheet for use If repair is required, write down so in the Remarks column.
  • Page 46 ※ For purpose of improvement, specifications and subject to change without notice. Jawon Medical Co.,Ltd HEAD OFFICE: 29, Gongdan 4-ro, Jillyang-eup, Gyeongsan-si, Gyeongsangbuk-do, 38470, Republic of Korea TEL: 82-53-856-0993, FAX: 82-53-856-0995 EUROPEAN REPRESENTATIVE: VITAKO Sp.

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