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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. z o.o.
UL. MALEJ SYRENKI 2 71-790 SZCZECIN, POLAND

TEL: 91 8522900 / 901, FAX: 91 8522910

Содержание EX plus 1300

Страница 1: ......

Страница 2: ...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 z o o UL MALEJ SYRENKI 2 71 790 SZCZECIN POLAND TEL 91 8522900 901 FAX 91 8522910 ...

Страница 3: ...1 2 LOADING THE PRINT PAPER 21 3 CONNECTING PORTS 23 4 CONNECTING PRINTER 23 5 CONNECTING PEDAL SWITCH 24 6 CONNECTING HAND SWITCH 24 SYSTEM SETUP 25 1 Entering SYSTEM SETUP 25 2 Menu 25 3 Entering MENU view 25 4 How to escape from SYSTEM SETUP 25 5 How to move into SYSTEM SETUP 25 6 SETUP 26 MEASUREMENT 30 1 CAUTIONS FOR MEASUREMENT 30 2 MEASUREMENT 31 3 RESULT SHEET 34 4 The measuring method if ...

Страница 4: ...4 1 AFTER SERVICE 41 2 PACKING AND TRANSPORT 41 SPECIFICATION 42 WARRANTY 43 ...

Страница 5: ...ve measurement device there are clinical conditions which can influence the accuracy of the results Also the subject s position physiological condition and other environmental factors can affect the measurement calculation The EX PLUS 1300 Non Invasive Blood Pressure Monitor should not be used with patients who have the following conditions 1 Patients with a known arrhythmia 2 Patients with insuff...

Страница 6: ...er the standard of EN 60601 1 2006 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 needed ask our company or its authorized dealer for service 4 The unit has previously been adjusted in the factory for optimum performance Do not attempt to adjust switches or any other things exce...

Страница 7: ...the following measures Reorient or relocate the receiving device Increase the separation between the equipment Connect the equipment into an outlet on a circuit different from that to which the other device s are connected Consult the manufacturer or field service technician for help 9 Do not to touch signal input signal output or other connectors and the patient simultaneously 10 a statement that...

Страница 8: ...formation contained in the product for diagnosis or treatment of health problem or prescription of medication by yourself If you have or suspect that you have a medical problem consult with your physician promptly Defective unit or accessories must be packed in the replacement cartons to be shipped off from you to our company Shipping and insurance costs for return of defective unit must be prepai...

Страница 9: ...tions for your safety Degree of protection against electric shock TYPE BF Please observe operating instructions General warning sign General prohibition sign General mandatory action sign Caution Waste Electrical and Electronic Equipment WEEE The device could be sent back to the manufacturer for recycling or proper disposal after their useful lives Alternatively the device shall be disposed in acc...

Страница 10: ... 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 CE mark Serial No ...

Страница 11: ...essurizing 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 ...

Страница 12: ... buildings used for domestic purposes Harmonic emissions IEC 61000 3 2 Class A Voltage fluctuations flicker emissions IEC 61000 3 3 Compliance 2 Guidance and manufacturer s declaration electromagnetic immunity 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 Immu...

Страница 13: ...typical location in a typical commercial or hospital environment Note UT is the a c mains voltage prior to application of the test level 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 Immunity...

Страница 14: ...ption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be c...

Страница 15: ...er W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d 1 2 80 MHz to 900 MHz d 1 2 900 MHz to 2 5 GHz d 1 2 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency o...

Страница 16: ...ted out Automatic cutter is equipped inside and it cuts the result sheet automatically CUFF It automatically wraps and releases the arm for measurement ARM REST When the arm is placed on the cuff it sustains the arm and makes the right position HUMAN SENSOR When a user approaches power is automatically turned on and vice versa When the user is wearing black it may not sense the movement Therefore ...

Страница 17: ...ST CUFF AUTOMATIC CUTTER EMERGENCY STOP BUTTON HUMAN SENSOR PRINTER COVER START STOP BUTTON LCD DISPLAY CLOCK SECTION INFORMATION BOARD HAND SWITCH HAND SWITCH REST The side part of cart The under part of cart PEDAL SWITCH ...

Страница 18: ...ety the device should be placed on the flat surface COMMUNICATION PORTS RS 232C It connects the main to other equipments with cable RS 232C to transfer the data USB PORT A TYPE It connects the main body with USB cable A type USB PORT B TYPE It connects the main body with USB cable B type PEDAL BUTTON PORT It connects the PEDAL switch HAND BUTTON PORT It connects the HAND switch INFORMATION BOARD F...

Страница 19: ...operator should not touch both USB port and the patient s body simultaneously COMMUNICATION PORT L CAL EARTH POWER INPUT R CAL POWER USB PORT B TYPE USB PORT A TYPE INFORMATION BOARD FIXER PEDAL BUTTON PORT HAND BUTTON PORT ...

Страница 20: ...20 3 ACCESSORIES 4 OPTIONS Thermal paper ROLLER PEDAL HAND SWITCH User Manual Adapter Power cable Information board Chair Cart A4 RESULT SHEET ...

Страница 21: ...rder 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 of the main body Wrong connection could be a fire hazard INSTALLATION ...

Страница 22: ... rough It prints the letter only on the smooth side Always check the remainder of the paper and replace it at any time When the red line appears on the right corner of the paper replace the paper Use only the exclusive paper 57mm Keep paper rolls in a dark and ventilated place Avoid the dust on the paper Do not pull the paper during printing It may cause a jam When the paper is not loaded correctl...

Страница 23: ...er 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 Insert USB cable to the communication port and connect it to the printer as shown in the picture below ...

Страница 24: ...24 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 ...

Страница 25: ...2 DATE TIME 3 VOLUME 4 PRINT 5 MEASUREMENT MODE 6 Automatic return to initialized screen 7 LOGO 8 PERSONAL DATA INPUT 9 VOICE 3 Entering MENU view Select the menu on the touch screen 4 How to escape from SYSTEM SETUP Press the blue icon on the upper right corner The initial screen appears 5 How to move into SYSTEM SETUP After setting the system from the selected menu press the blue icon on the upp...

Страница 26: ...te by following the instructions mentioned above Save the change with SET button Press CLOSE to get back to SYSTEM SETUP menu Note Press CLOSE to stop setting the date and time For Date Time all settings should be done at once hour minute month day and year If you press CLOSE and stop the setting the time and date returns to the old setting The function of Time and Calendar keeps running even afte...

Страница 27: ...nt mode Select the MEASUREMENT MODE and enter the menu Select either SIMPLE MEASUREMENT MODE or Three Measurement MODE Set the interval time when Three Measurement MODE is selected The interval time is the break time between three times of measurements Select the time from 15sec 30sec 45sec and 60sec Press SET to save the change Press CLOSE to get back to SYSTEM SETUP menu CONVERTING TO AUTO STAND...

Страница 28: ...e voice guidance Pre set ON Select Voice and enter the menu Select either ON or OFF Press SET to save the change Press CLOSE to get back to SYSTEM SETUP menu PRINT It selects the printing mode of the A4 printer The printer and pre formatted result sheet is optional Select PRINT and enter the menu Pre set AUTO AUTO It is printed automatically Manual It is printed manually Off It is not printed Pres...

Страница 29: ...button on touch pad to save it Press CLOSE to get back to SYSTEM SETUP menu Note L R left right is moving to the left and is moving to the right U D up down is moving up and is moving down PROGRAM INFORMATION It is for check the program information of this device Select PROGRAM INFORMATION and enter the menu Check the version and information of this program Press CLOSE to get back to SYSTEM SETUP ...

Страница 30: ...alf sitting leg crossed Put your arm properly into the arm support When you roll up the sleeves make sure that the rolled up sleeves are not pressing the upper arms When the pulse is running too week and hard to be heard from stethoscope EX PLUS 1300 can not make a measurement During the measurement straighten your back and relax your arm Caution This device is only for adult MEASUREMENT ...

Страница 31: ...e appears as shown in the picture Put both arms into the cuff There s Pedal Switch placed at the bottom of the cart Step down the pedal to start the measurement Caution Place your arm on the arm supporter with the palm facing up Adjust the height of the chair so that the arm stays on the same height of the heart When the arm is placed lower than the heart blood pressure will be higher than actual ...

Страница 32: ...e Note When the difference between the two arms is more than 20mmHg for systolic blood pressure or 10mmHg for diastolic blood pressure the difference is indicated in red The result is printed out automatically Note At the system setup there s PRINT ON OFF If the print is off the result sheet is not printed out Pull your arm out from the cuff When you press button on the result screen it indicates ...

Страница 33: ...tomatically from the cuff and LCD indicates the current status The next step is same as the instruction from 1 Measuring method by using a foot switch 3 Measuring method by one arm Measure blood pressure on one arm Plug the cable and turn on the power As the power is on LCD displays the Standby mode Put right or left arm to the cuff Note For measuring right arm put right arm into the cuff on the r...

Страница 34: ...een 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 Result sheet format both arms Result sheet format one arm ...

Страница 35: ... ID Enter SYSTEM SETUP From PERSONAL DATA INPUT activate ID use Input data ID On the initial display press ID Enter ID using the number buttons ID Input Range is from 000000001 to 999999999 Weight After entering ID press WEIGHT Enter weight Weight Input Range is 10 0 248 0kg Height After entering weight press HEIGHT Enter height Height Input Range is 80 0 238 0cm ...

Страница 36: ...ody Mass Index B M I It is a health indicator kg m 2 EAST ASIA section thin normal overweight obese 18 5kg m 2 18 5 23 0kg m 2 23 0 25 0kg m 2 25 0kg m 2 and over EU and etc section thin normal overweight obese 18 5kg m 2 18 5 25 0kg m 2 25 0 30 0kg m 2 30 0kg m 2 and over Fatness Based on the standard weight it calculates how fat the user is in percentage current weight standard weight standard w...

Страница 37: ...ree measurement mode You can set the measuring interval 15sec 30sec 45sec 60sec Measurement Put both arms or one arm to the cuff and press START button Pressurization starts automatically from the cuff and LCD indicates the current status When the first measurement is completed device stops until the interval time the user sets When the second measurement is completed device stops until the interv...

Страница 38: ...38 Result After the third measurements the average blood pressure is indicates as follows ...

Страница 39: ...ign substances or exposing to particular environment this device must be examined by an expert before use 11 Use the power cable plug and fuse that are offered by our company At this time confirm the covering of cable the state of plug connection and other check points to the things below RS 232C cable USB port Adapter 12 When pulling out the power cable turn off the power switch first and then pu...

Страница 40: ...essage is repeated call for maintenance service ERROR CUFF pressure is low as air leaks When the message is repeated call for maintenance service ERROR MEASURE subject moves or speaks while in testing Don t move or speak When the message is repeated call for maintenance service ERROR REPAIR ...

Страница 41: ...ntact 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 PACKING AND TRANSPORT Our company wraps this device up with the most suitable m...

Страница 42: ... Pressure 30 300mmHg Pulse 30 200beats minute Accuracy Pressure 3mmHg Pulse With in 3 Resolving Power 1mmHg Pressurizing method DC Motor Cuff type Double cuff with automatic pressurization Pressurizing time Approx 20 seconds Measuring time Approx 50 seconds Printer High speed thermal printer Power supply Input AC 100 240V 50 60Hz 1 5A Output DC 12V 5A 60VA ADAPTER Power consumption 96VA Operating ...

Страница 43: ... Date of purchase Month Day Year Customer Name TEL Address Dealer Name TEL 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 This warranty will not be reissued please keep it in a safe place WARRANTY ...

Страница 44: ... 1 Keys Smooth operation Pass Fail 2 Recorder Smooth operation with no abnormal sound Pass Fail 3 Cuffs Smooth operation Pass Fail Accessories 1 Power cord Smooth operation and removal Pass Fail Electrical Check Performance 1 Power supply Screen display upon power on Pass Fail 2 Display No abnormality and flickering Pass Fail 3 Printing printing possible Pass Fail 4 Measurement Proper measurement ...

Страница 45: ...mooth operation Pass Fail 2 Recorder Smooth operation with no abnormal sound Pass Fail Accessories 1 Power cord Smooth operation and removal Pass Fail Electrical Check Performance 1 Power supply Screen display upon power on Pass Fail 2 Display No abnormality and flickering Pass Fail 3 Printing Waveform printing possible Pass Fail 4 Measurement Proper measurement Pass Fail Other 1 Clock Present dat...

Страница 46: ...hen you ask for service the manufacturer s label serial number date of original purchase and explanation of malfunction will be required HEAD OFFICE 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 EUROPEAN REPRESENTATIVE VITAKO Sp z o o UL MALEJ SYRENKI 2 71 790 SZCZECIN POLAND TEL 91 8522900 901 FAX 91 8...

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