RIXFT-500Fully Automated Blood Pressure Monitor

1. INTRODUCTION3 2 WORD DEFINITIONS3 3. CLASSIFICATION AND COMPLIANCE4 4. SAFETY PRECAUTIONS4 5. SAFETY SYMBOLS6 1. FRONT PART7 2. PRINTER9 3. REAR PART10 4. ACCESSORIES12 5. OPTIONS12 1. CONNECTING POWER CABLE(AC INPUT)13 2. ASSEMBLING OF ARM REST13 3. LOADING THE PRINT PAPER14 4. CONNECTING PORTS(RS-232C)14 5. SETTING TIME AND DATE15 1. CAUTION FOR MEASUREMENT16 2. MEASUREMENT17 3. DATA ON MEASUREMENT BY PRINTER20 21 1. AFTER SERVICE24 2. PACKING AND TRANSPORT24 25 26 We highly appreciate you choose this JAWON product. You are kindly requested to be familiar with these directions before using this product and always keep it together with the product. In case you are not clear about any directions or problems arising while using the product, please contact our service center. We will provide you with detailed instructions. 1. INTRODUCTION FT-500 (R/L) is a state-of-the-art medical equipment that can check not only blood pressure and the pulse rate but also Pressure Rate Product (PRP - an important index for the oxygen consumption of cardiac muscle) through a single process. This machine will help to provide upgraded medical services for the patients since more accurate and reliable diagnosis is collected and suitable treatments can be arranged on the basis of these measured results. FT-500 (R/L) is the fully automated blood pressure monitor armed with the belt-type cuff that facilitates the test time quicker and provides the results more reliable. 2. WORD DEFINITIONS To ensure safe operation and long term performance stability, it is essential that you fully understand the functions, operating and maintenance instructions by reading this manual before operating your unit. Particular attention must be paid to all warnings, cautions and notes incorporated herein. The following conventions are used throughout the manual to denote information of special emphasis. WARNING Important information to indicate the presence of a hazard which can cause severe personal injury, death of substantial property damage if the warning is ignored. CAUTION Important information to indicate the presence of a hazard which will or can cause minor personal injury or property damage if the warning is ignored. NOTE Important information to notify the user of installation, operation, or maintenance information which is important but not hazard-related. Hazard warning should never be included under the note signal word. 3. CLASSIFICATION AND COMPLIANCE 1) FT-500(R/L) 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 IEC 60601-1(Safety of Medical Electrical Equipment) 2) FT-500(R/L) are complied with Class A for Noise-Emission, Level B for Noise-immunity, by standard of IEC 60601-1-2(Electromagnetic Compatibility Requirements). 3) This blood pressure meter complies with the EN 1060-1 : 1995 Non-invasive Sphygmomanometers general requirements as well as EN 1060-3 : 1997 supplementary requirements for electro-mechanical blood pressure measuring systems. 4. SAFETY PRECAUTIONS FT-500(R/L) is designed and manufactured with consideration given to the safety of the operator and subject and also to the reliability of the unit. The following precautions must be observed for additional safety ; 1) The unit must be operated only by, or under supervision of, a qualified person by JAWON or his distributor. 2) FT series are specified as Class 1 type BF unit under the standard of IEC 60601-1(Safety of Medical Electrical Equipment). Therefore, patients must not touch or handle inner side of the system at any time. 3) Do not modify the unit. If any modification is desired, ask JAWON or its authorized dealer for service. 4) The unit has been factory-adjusted for optimum performance. Do not attempt to adjust any pre-controls or switches except those specified in this manual for operation. 5) If you have experienced any trouble with the unit, switch it off immediately, and contact JAWON or its authorized dealer for assistance. 6) If you plan to connect any device of other manufacturers electrically or mechanically to this unit, contact JAWON or its authorized dealer for instructions before doing so. When you connect computer or other system to the unit(RS-232C), the attached systems should be certified by IEC 950 or equivalent standards for data processing equipment. Configurations shall comply with the system standard IEC60601-1-1. Everybody who connects additional equipment to the signal input part or signal output part configures a medical system standard IEC 60601-1-1. If in doubt, consult the A/S department of local distributor. 7) Avoid the following environments for storage ; - Where the ambient temperature falls -5 or exceeds 50. - Where the atmospheric pressure falls below 70 kPa(700 mbar) or exceeds 106kPa (1060 mbar). - Where the humidity is over 85% non-condensing. - Where the unit is exposed to spray or splashing water. - Where the unit is exposed to dust, - Where the unit is exposed to water vapor. - Where the unit is exposed to high density oil 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. - Where the AC power line voltage heavily fluctuates - Where the AC power line voltage changes heavily when this unit is in operation. - Where the unit is exposed to direct sunlight. Note Incorrect operation or failure of user to maintain the unit relieves the manufacturer or his agent of the system's non-compliance with specifications or responsibility for any damage or injury. This manual is made for informational purpose and this manual and product are not meant to be a substitute for the advice provided by your own physcian or other medical problem. You should not use this infor…

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Date : September 25, 2003 Federal Communication Commission Authorization and Evaluation Division Equipment Authorization Branch 7435 Oakland Mills Road Subject : Confidentiality Request regarding application for certification of FCC IS: RIXFT-700 Pursuant to Section 0.457 and 0.459 of the commission’s Rules, We hereby request confidential treatment of information accompany this application as outlined bellow; Block Diagram The above material contain trade secrets and proprietary information not customarily released to public. The public disclosure of these materials may be harmful to the applicant The applicant understands that pursuant to section 0.457 of the Rules, Disclosure of this application and all accompanying documentation will not be made before the date of the Grant for this application Sincerely Signature Name : Yo Han, Park Title : Chief Engineer of EMC Team Company : E-Rae Testing Laboratory Inc. 584, Sangwhal-Ri, Kanam-Myun, Yoju-Kun, Kyounggi-Do, 469-885, Korea Tel : +82-31- 885-0072, 0073 Fax : +82-31-885-0074

Appendix D. Internal Photographs ETL Inc. #584 Sangwhal-ri, Kanam-myon, Yoju-kun, Kyounggi-do, 469-880, Korea 1 of 1 Jawon medical CO., LTD. Full Automated Blood Pressure Monitor Model: FT-500L FCC ID: RIXFT-500 Report No: E03.0925.FCC.491N Component side view of Inside Solder side view of Inside Appendix D. Internal Photographs ETL Inc. #584 Sangwhal-ri, Kanam-myon, Yoju-kun, Kyounggi-do, 469-880, Korea 2 of 2 Jawon medical CO., LTD. Full Automated Blood Pressure Monitor Model: FT-500L FCC ID: RIXFT-500 Report No: E03.0925.FCC.491N Component side view of Main Appendix D. Internal Photographs ETL Inc. #584 Sangwhal-ri, Kanam-myon, Yoju-kun, Kyounggi-do, 469-880, Korea 3 of 3 Jawon medical CO., LTD. Full Automated Blood Pressure Monitor Model: FT-500L FCC ID: RIXFT-500 Report No: E03.0925.FCC.491N Solder side view of Main Appendix D. Internal Photographs ETL Inc. #584 Sangwhal-ri, Kanam-myon, Yoju-kun, Kyounggi-do, 469-880, Korea 4 of 4 Jawon medical CO., LTD. Full Automated Blood Pressure Monitor Model: FT-500L FCC ID: RIXFT-500 Report No: E03.0925.FCC.491N Component side view of LED Panel Solder side view of LED Panel Appendix D. Internal Photographs ETL Inc. #584 Sangwhal-ri, Kanam-myon, Yoju-kun, Kyounggi-do, 469-880, Korea 5 of 5 Jawon medical CO., LTD. Full Automated Blood Pressure Monitor Model: FT-500L FCC ID: RIXFT-500 Report No: E03.0925.FCC.491N Component side view of Power board Solder side view of Power board Appendix D. Internal Photographs ETL Inc. #584 Sangwhal-ri, Kanam-myon, Yoju-kun, Kyounggi-do, 469-880, Korea 6 of 6 Jawon medical CO., LTD. Full Automated Blood Pressure Monitor Model: FT-500L FCC ID: RIXFT-500 Report No: E03.0925.FCC.491N Component side view of Card Reader board Solder side view of Card Reader board Appendix D. Internal Photographs ETL Inc. #584 Sangwhal-ri, Kanam-myon, Yoju-kun, Kyounggi-do, 469-880, Korea 7 of 7 Jawon medical CO., LTD. Full Automated Blood Pressure Monitor Model: FT-500L FCC ID: RIXFT-500 Report No: E03.0925.FCC.491N Component side view of Printer board Solder side view of Printer board Appendix D. Internal Photographs ETL Inc. #584 Sangwhal-ri, Kanam-myon, Yoju-kun, Kyounggi-do, 469-880, Korea 8 of 8 Jawon medical CO., LTD. Full Automated Blood Pressure Monitor Model: FT-500L FCC ID: RIXFT-500 Report No: E03.0925.FCC.491N Component side view of DC Motor Solder side view of DC Motor Appendix D. Internal Photographs ETL Inc. #584 Sangwhal-ri, Kanam-myon, Yoju-kun, Kyounggi-do, 469-880, Korea 9 of 9 Jawon medical CO., LTD. Full Automated Blood Pressure Monitor Model: FT-500L FCC ID: RIXFT-500 Report No: E03.0925.FCC.491N Component side view of Main Front board Solder side view of Main Front board Appendix D. Internal Photographs ETL Inc. #584 Sangwhal-ri, Kanam-myon, Yoju-kun, Kyounggi-do, 469-880, Korea 10 of 10 Jawon medical CO., LTD. Full Automated Blood Pressure Monitor Model: FT-500L FCC ID: RIXFT-500 Report No: E03.0925.FCC.491N Component side view of Sensor board Solder side view of Sensor board Appendix D. Internal Photographs ETL Inc. #584 Sangwhal-ri, Kanam-myon, Yoju-kun, Kyounggi-do, 469-880, Korea 11 of 11 Jawon medical CO., LTD. Full Automated Blood Pressure Monitor Model: FT-500L FCC ID: RIXFT-500 Report No: E03.0925.FCC.491N Component side view of Printer Front board Solder side view of Printer Front board Appendix D. Internal Photographs ETL Inc. #584 Sangwhal-ri, Kanam-myon, Yoju-kun, Kyounggi-do, 469-880, Korea 12 of 12 Jawon medical CO., LTD. Full Automated Blood Pressure Monitor Model: FT-500L FCC ID: RIXFT-500 Report No: E03.0925.FCC.491N View of Oscillometric

ETL Inc. #584 Sangwhal-ri, Kanam-myon, Yoju-kun, Kyounggi-do, 469-880, Korea 5 of 16 FCC ID: RIXFT-500 Report No: E03.0925.FCC.491N Jawon medical CO., LTD. Fully Automated Blood Pressure Monitor Model: FT-500L 2.1 Equipment Description The Equipment Under Test(EUT) is the Jawon medical CO., LTD. Fully Automated Blood Pressure Monitor, FT-500L. 2.2 General Specification l Model : FT-500L l Display Mode : LED display l Measuring ranges : Pressure : 30 ~ 300mmHg Pulse : 30 ~ 200beats/min l Accuracy : Pressure : ±2mmHz, pulse : ±5% l Resolving Power : 1mmHg l Pressurizing method : DC Motor l Cuff : Belt type l Prressurizing time : Approx. 10seconds l Measuring time : Approx. 33seconds l Measuring method : Oscillometric l Printer : Thermal high-speed Printer l Power supply : 230V~/50Hz(EC), AC120V/60Hz(US) l Power consumption : 50VA l Ambience for operation : Temperature : 10~40°C, Humidity : Less then 85% non-condensing l Ambience for storge : Temperature : -5~50°C, Humidity : Less then 85% non-condensing l Data transmission : RS-232C l Dimensions 480(W) * 310(D) * 290(H)mm l Weight Approx. 11kg l Measuring : FT-500L : with left arm

www.etl.re.kr ETL Inc. This report only responds to the tested sample and may not be reproduced, except in full, without written approval of the ETL,Inc. Electromagnetic Emission FCC MEASUREMENT REPORT CERTIFICATION OF COMPLIANCE FCC Part 15 Certification Measurement This Fully Automated Blood Pressure Monitor, Model FT-500L has been tested in accordance with the measurement procedures specified in ANSI C63.4-1992 at the ETL/EMC Test Laboratory and has been shown to be complied with the electromagnetic radiated emission limits specified in FCC Rule Part 15 Subpart B : I attest to the accuracy of data. All measurement herein were performed by me or were made under my supervision and are correct to the best of my knowledge and belief. I assume full responsibility for the completeness of these measurements and vouch for the qualifications of all persons taking them. The results of testing in this report apply to the product/system which was tested only. Other similar equipment will not necessarily produce the same results due to production tolerance and measurement uncertainties. Yo Han, Park / Chief Engineer ETL Inc. #584 Sangwhal-ri, Kanam-myon, Yoju-kun, Kyounggi-do, 469-880, Korea PRODUCT : Fully Automated Blood Pressure Monitor MODEL/TYPE NO : FT-500L FCC ID : RIXFT-500 APPLICANT : Jawon medical CO., LTD. ADDRESS : 13Lot, 21 block Jinryang Industrial Complex, Kyung-san city, Kyung-buk, Korea Attn. : Jong-Hwan Cho / Senior engineer , R&D center FCC CLASSIFICATION : Class B personal computers and peripherals FCC RULE PART(S) : FCC Part 15 Subpart B FCC PROCEDURE : Certification TRADE NAME : Jawon medical TEST REPORT No. : E03.0925.FCC.491N DATES OF TEST : September 22 ~ 24, 2003 DATES OF ISSUE : September 25, 2003 TEST LABORATORY : ETL Inc ( FCC Registration Number : 95422) #584 Sangwhal-ri, Kanam-myon, Yoju-kun, Kyounggi-do, 469-880, Korea Tel : (031) 885-0072 Fax : (031) 885-0074 ETL Inc. #584 Sangwhal-ri, Kanam-myon, Yoju-kun, Kyounggi-do, 469-880, Korea 2 of 16 FCC ID: RIXFT-500 Report No: E03.0925.FCC.491N Jawon medical CO., LTD. Fully Automated Blood Pressure Monitor Model: FT-500L Table of Contents FCC Measurement Report 1. Introduction 2. Product Information 3. Description of Tests 4. Test Condition 5. Test Results 5.1 Summary of Test Results 5.2 Conducted Emissions Measurement 5.3 Radiated Emissions Measurement 6. Sample Calculations 7. List of test Equipment used for Measurement Appendix A. FCC ID Label and Location Appendix B. Test Setup Photographs Appendix C. External Photographs Appendix D. Internal Photographs Appendix E. Block Diagram Appendix F. User Manual ETL Inc. #584 Sangwhal-ri, Kanam-myon, Yoju-kun, Kyounggi-do, 469-880, Korea 3 of 16 FCC ID: RIXFT-500 Report No: E03.0925.FCC.491N Jawon medical CO., LTD. Fully Automated Blood Pressure Monitor Model: FT-500L FCC MEASUREMENT REPORT Scope – Measurement and determination of electromagnetic emission(EME) of radio frequency devices including intentional radiators and/or unintentional radiators for compliance with the technical rules and regulations of the U.S Federal Communications Commission(FCC) General Information l EUT Type : Fully Automated Blood Pressure Monitor l Model Number : FT-500L l FCC ID : RIXFT-500 l S/N : N/A l FCC Rule Part(s) : FCC Part 15 Subpart B l Test Procedure : ANSI C63.4-1992 l FCC Classification : Class B personal computers and peripherals l Dates of Tests : September 22~24, 2003 l Place of Tests : ETL Inc EMC Testing Lab (FCC Registration Number : 95422) 584, Sangwhal-Ri, Kanam-Myun, Yoju-Kun, Kyounggi-Do, Korea Tel : (031) 885-0072 Fax : (031) 885-0074 l Test Report No. : E03.0925.FCC.491N Applicant Name : Jawon medical CO., LTD. Address : 13Lot, 21 block Jinryang Industrial Complex, Kyung-san city, Kyung-buk, Korea Attention : Jong-Hwan Cho / Senior engineer , R&D center ETL Inc. #584 Sangwhal-ri, Kanam-myon, Yoju-kun, Kyounggi-do, 469-880, Korea 4 of 16 FCC ID: RIXFT-500 Report No: E03.0925.FCC.491N Jawon medical CO., LTD. Fully Automated Blood Pressure Monitor Model: FT-500L The measurement test for radiated and conducted emission test were conducted at the open area test site of E-RAE Testing Laboratory Inc. facility located at 584, Sangwhal-ri, Ganam-myun, Youju-kun, Kyoungki-do, Korea. The site is constructed in conformance with the requirements of the ANSI C63.4-1992 and CISPR Publication 16. The ETL has site descriptions on file with the FCC for 3 and 10meter site configurations. Detailed description of test facility was found to be in compliance with the requirements of Section 2.948 FCC Rules according to the ANSI C63.4-1992 and registered to the Federal Communications Commission(Registration Number : 95422 ). The measurement procedure described in American National Standard for Method of Measurement of Radio-Noise Emission from Low-Voltage Electrical and Electronic Equipment in the Range of 9kHz to 40GHz (ANSI C.63.4-1992) was used in determining radiated and conducted emissions from the Jawon medical CO., LTD. , Model : FT-500L ETL Inc. #584 Sangwhal-ri, Kanam-myon, Yoju-kun, Kyounggi-do, 469-880, Korea 5 of 16 FCC ID: RIXFT-500 Report No: E03.0925.FCC.491N Jawon medical CO., LTD. Fully Automated Blood Pressure Monitor Model: FT-500L 2.1 Equipment Description The Equipment Under Test(EUT) is the Jawon medical CO., LTD. Fully Automated Blood Pressure Monitor, FT-500L. 2.2 General Specification l Model : FT-500L l Display Mode : LED display l Measuring ranges : Pressure : 30 ~ 300mmHg Pulse : 30 ~ 200beats/min l Accuracy : Pressure : ±2mmHz, pulse : ±5% l Resolving Power : 1mmHg l Pressurizing method : DC Motor l Cuff : Belt type l Prressurizing time : Approx. 10seconds l Measuring time : Approx. 33seconds l Measuring method : Oscillometric l Printer : Thermal high-speed Printer l Power supply : 230V~/50Hz(EC), AC120V/60Hz(US) l Power consumption : 50VA l Ambience for operation : Temperature : 10~40°C, Humidity : Less then 85% non-condensing l Ambience for storge : Temperature : -5~…

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Appendix B. Test Setup Photographs ETL Inc. #584 Sangwhal-ri, Kanam-myon, Yoju-kun, Kyounggi-do, 469-880, Korea 1 of 1 Jawon medical CO., LTD. Full Automated Blood Pressure Monitor Model: FT-500L FCC ID: RIXFT-500 Report No: E03.0925.FCC.491N Radiated Emission Test Setup Appendix B. Test Setup Photographs ETL Inc. #584 Sangwhal-ri, Kanam-myon, Yoju-kun, Kyounggi-do, 469-880, Korea 2 of 2 Jawon medical CO., LTD. Full Automated Blood Pressure Monitor Model: FT-500L FCC ID: RIXFT-500 Report No: E03.0925.FCC.491N Conducted Emission Test Setup