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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

SELVAS Healthcare, Inc.

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. Stanisława Żaryna 7c 02-593 Warszawa, POLAND

TEL: +48 22 400 8000

Содержание BC360

Страница 1: ......

Страница 2: ...THE PERSONS RESPONSIBLE FOR PLACING DEVICES ON THE EC MARKET UNDER MDD 93 42 EEC SELVAS Healthcare Inc 29 Gongdan 4 ro Jillyang eup Gyeongsan si Gyeongsangbuk do 38470 Republic of Korea TEL 82 53 856...

Страница 3: ...ice 23 INSTALLATION 26 1 Power Supply 26 2 Peripheral Device Installation 27 1 Connecting Computer 27 2 Connecting Printer 28 3 Connecting Blood Pressure Monitor 29 4 Connecting ultrasonic height mete...

Страница 4: ...ERPRETATION 53 STORAGE MAINTENANCE 57 ERROR REPAIR 58 1 Kinds of Error Repair 58 2 Error Occurrence Repair 60 AFTER SERVICE 61 1 AFTTER SERVICE 61 2 PACKING AND TRANSPORT 61 SPECIFICATION 62 WARRANTY...

Страница 5: ...n change etc 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 t...

Страница 6: ...rnings precautions and notes must be observed for safety Warning During measurement of the body composition a microcurrent of 180 A flows through the body Individuals who have any kind of implanted ac...

Страница 7: ...standard EN 60601 1 2006 If in doubt consult the A S department of local distributor Caution Avoid the following environments for storage Where the ambient temperature falls below 25 C or exceeds 70 C...

Страница 8: ...fied as Class 1 type BF unit under the standard EN 60601 1 2006 Basic safety and essential performance of Medical Electrical Equipment Therefore patients must not touch or handle inner side of the sys...

Страница 9: ...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 f...

Страница 10: ...tion contained in the product for diagnosis or treatment of health problems or prescription of medication by yourself If you have or suspect that you have a medical problem consult with your physician...

Страница 11: ...our 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 Electrica...

Страница 12: ...und 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 Authorize...

Страница 13: ...used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The ACCUNIQ BC360 uses RF energy only for its internal function Therefore its R...

Страница 14: ...ality should be that of a typical commercial or hospital environment Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be t...

Страница 15: ...Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Conducted RF IEC 61000 4 6 Radiated RF IEC 61000 4 3 3 Vrms 150 kHz to 80 MHz 3 V m 80 MHz to 2 5 GHz 3 Vrms 3...

Страница 16: ...tters 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 as...

Страница 17: ...uency of transmitter m Rated maximum output power of transmitter W 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...

Страница 18: ...the key factor in obesity assessment is the amount of fat accumulated in the body In general obesity is defined as the state of not only excessive weight compared with height visible obese but also e...

Страница 19: ...sceral fat increases after 30s in men and after Menopause in women It is more common in men than women and the old than the young Visceral fat tends to increase with aging Because the combustion rate...

Страница 20: ...of as follows Main body User manual Adapter USB Cable Data management program Bolts 5mm L wrench Body Cover Model or specification of accessories can be changed according to market supply and demand U...

Страница 21: ...the measurer s blood pressure 3 A4 result sheet for segmental parts and children It shows the segmental results and children growth curve to make users easily understand the condition of 5 body parts...

Страница 22: ...s height more accurately and quickly It employs standoff determination method using ultrasonic sensor Note Measuring height in the morning is average 1 2cm higher than in the evening Vertebral cartila...

Страница 23: ...displays the procedure and results Handle Electrode Handle Electrode measure the impedance by sending harmless electric current to the body Hold them with the hands during measurement Start button Sta...

Страница 24: ...essure port Connecting blood pressure monitor OPTION by SELVAS Healthcare Inc USB A port Connecting the printer offered with this device USB B port Connecting a computer Adapter port ADAPTER Connectin...

Страница 25: ...25 3 Base Part Weight scale It consists of four plate electrodes and it measures weight Plate electrode It measures the impedance The user should step it in bare feet Weight scale Plate electrode...

Страница 26: ...vice and the peripheral devices are connected each other the order of turning of the devices should start from the device to keep the functions and safe of the device 3 This device should be only powe...

Страница 27: ...r should be installed at first For more information please refer to the manual CD of software Note 1 In order to save search and retrieve the users data the user should connect the analyzer to the com...

Страница 28: ...the USB A port placed on the rear panel of this device with USB cable Connecting the device computer and the printer Connect a computer to the USB B jack placed on the rear panel of the device with U...

Страница 29: ...pressure monitor of our company Option Connect a blood pressure monitor to BLOOD PRESSURE RS 232C jack placed on the rear panel of the device with blood pressure monitor cable 4 Connecting Ultrasonic...

Страница 30: ...ts out Close the cover and fix the printer cover by turning the screws clockwise 5 1 FEED CUT functions of thermal printer FEED Function Press upper left corner for 5seconds on the initial screen Pass...

Страница 31: ...M SETUP Menu items are displayed The function of each icon is as follows 1 DATE TIME 2 VOLUME 3 PRINT 4 PRINT POSITION 5 CLOTHES 6 SCALE OFFSET 7 ABDOMINAL FATNESS 8 DATE TYPE 9 THERMAL PRINT 10 COMMU...

Страница 32: ...one s desire and confirm changes using SET button 4 Exiting SYSTEM SETUP Press CLOSE button on SYSTEM SETUP phase then back to initial view of the analyzer 5 Moving to SYSTEM SETUP Press CLOSE button...

Страница 33: ...VOLUME on SYSTEM SETUP screen with button and press SET on touch pad Pre set 3 Range 0 9 Adjust volume with button on touch pad Press SET on touch pad to save selected value Return to SYSTEM SETUP sc...

Страница 34: ...sing button moves print position down or right Pressing button moves print position up or left Every single press moves print position by about 0 2 mm Press SET button on touch pad to save it Return t...

Страница 35: ...d in body composition analysis Select SCALE OFFSET on SYSTEM SETUP screen and press SET on touch pad Pre set 0 0 kg Range 9 9 9 9 kg Set the value with button in touch screen Every single press change...

Страница 36: ...ERMAL PRINT on SYSTEM SETUP screen and press SET button on touch pad Pre set OFF Choose AUTO or MANUAL or OFF on touch pad Press SET button on touch pad to save it Return to SYSTEM SETUP screen by pre...

Страница 37: ...ld input basic information before the test starts 2 If FLASH MEMORY is selected the results are saved in flash memory in the machine itself If USB MEMORY is selected the results are saved in portable...

Страница 38: ...D Only the child growth curve is not printed in case of 18 or over 18 ADULT No matter what age is set it prints the result sheet for ADULT The child growth percentile is presented on the ADULT result...

Страница 39: ...the main unit to external memory connect the external memory to the back and press the Backup button You can see the total number of saved data and the backup progress Please wait for backup to compl...

Страница 40: ...e used on the left upper side of the screen Press ID on the screen and enter an index number and press button Then you can search or see the results and print them 3 Setting a measurement mode Users c...

Страница 41: ...una exercise or activity that sweats a lot Or measure before these actions Avoid drinking alcohol 24 hours before the measurement Wear clothes as light as possible Once the subject is on the scale avo...

Страница 42: ...ange of body composition 2 Correct position to measure 1 How to touch electrodes Make sure that the plate electrodes are clean Take off the socks or stockings then stand on the plate electrodes Remove...

Страница 43: ...0 from the body O Correct grip X Imbalanced touch X Grip with only palm Note If 8 electrodes are not perfectly touched during the measurement the result is not reliable or the device quits the measure...

Страница 44: ...easurement will be stopped if all eight electrodes are not fairly touched 3 Measurement 1 Basic Analysis Weight measurement When the subject steps on the scale the screen changes with a chime bell Do...

Страница 45: ...e screen changes as shown in the picture Fit feet on plate electrodes accurately Note 1 If ID is already registered in previous time input ID and press The data of Height Gender and age saved in ID au...

Страница 46: ...is presented with graph and numerical value so it is understood easily Note 1 Press both start buttons for 2 seconds Do not move or bend the arms until the measurement is completed Measuring time is...

Страница 47: ...from the server in which it is saved Note 1 Scan the QR code with a QR code reader in a smart mobile device 2 The data saved in the server could be damaged or lost due to a problem with the server Re...

Страница 48: ...result of weight and height on the LCD With the chime bell you can start inputting the person data The input order is ID age and gender except height After it the measurement process is performed same...

Страница 49: ...Turn on the power of BPM and the computer Turn on the device Input personal data to create a new ID or input an ID which is already registered Measure blood pressure first Measure body composition The...

Страница 50: ...On selecting USB MEMORY When USB MEMORY is selected measurement data will be stored to USB MEMORY without notification Data can only be saved when USB MEMORY is inserted only at the initial screen of...

Страница 51: ...l data were deleted will appear Press Close to return to initial screen Deleted data can not be restored Note 1 USB memory should be inserted only at the initial screen 2 When there s no data saved in...

Страница 52: ...heet There are two kinds of result sheet One is for body composition analysis and the other is for segmental assessment For Body composition analysis Users can see the overall body composition analysi...

Страница 53: ...oses of body water and protein Mineral It composes of bone and electrolyte Protein this is a major element that composes soft lean mass together with body water T B W Total Body Water It consists of i...

Страница 54: ...th of hip than waist If body fat in abdomen increases the risk to cardiovascular diseases diabetes etc becomes higher 1 W H R Waist to Hip Ratio W H R is calculated by dividing waist girth by hip girt...

Страница 55: ...of the subject with the actual analyzed body composition It can be used to evaluate the subject s health and body development 8 Total score It is a physical total score which is evaluated considering...

Страница 56: ...lling 0 5kg per week is the most reasonable weight control method Control guide and calorie prescription are proposed value for one s body type 14 Body composition change Check to change of weight bod...

Страница 57: ...able 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...

Страница 58: ...re is neither something with wrong input of personal data age gender nor with measuring error of weight and impedance try again It can t measure if the P B F is out of range When the same error occurs...

Страница 59: ...be entered Can t measure the weight When the subject s weight deviates from the limit Measuring error Moving during the measurement Measure the weight again Don t move or speak during measurement It...

Страница 60: ...in correctly Try to measure again after cleaning the electrode holders with soft gauze Try again after cleaning the hands and soles Check if foreign materials are between electrodes and measuring part...

Страница 61: ...are designated by our company as repairable How to contact our company Write us at SELVAS Healthcare Inc 29 Gongdan 4 ro Jillyang eup Gyeongsan si Gyeongsangbuk do Korea TEL 82 53 856 0993 FAX 82 53...

Страница 62: ...for Child and Youth optional Body Composition Analysis Weight LBM Body fat SLM Protein Mineral TBW Muscle Fat analysis Weight SMM Fat mass Obesity analysis BMI PBF WHR Child growth curve height weigh...

Страница 63: ...63 Storage ambient Ambient temperature range 25 to 70 C Relative humidity range lower than 93 RH For purpose of improvement specifications and design are subject to change without notice...

Страница 64: ...f warranty Within 1 year from the date of purchase Date of purchase Customer Add Name Tel Dealer market Add Name Tel Note When you receive this warranty make sure that the name of the dealer and the m...

Страница 65: ...king and transport 1 Components 2 Unpacking UP mark should be indicated on the top side of the box when you place the Carton box on a surface Remove the strap with a scissor or a knife Make sure not g...

Страница 66: ...he air pack for protecting products Take out the protection air pack and check its components inside 3 Installation More than two workers hold the device and lift it up Take the device out of the Cart...

Страница 67: ...son is holding the column remove the plastic package from the Body and scale While the one person is holding the column another inserts two M6 bolts into each side of column and fixes them using 4mm 6...

Страница 68: ...68 4 Assembling the body cover Push the body cover in the arrow direction shown in the picture below and adhere to the scales packing Tight contact Body cover...

Страница 69: ...Connect the power Check the level of the device If it is not at level adjust the level using the four wheels After adjusting the level connect the provided adapter and power cable and turn on the dev...

Страница 70: ...and spread a peach of vinyl or paper on the floor to lay down the height meter Take away foreign substance and sharp things from the floor It might cause damage Open the boxes of the height meter sup...

Страница 71: ...prop or books to support the column so that LCD would not touch the ground Place the handle electrodes at a safe spot Before the bottom plate of the height meter is attached to the bottom plate of the...

Страница 72: ...nch bolts to the appropriate holes and fasten them tightly Use 3mm wrench tool for M4 wrench bolts Use 5mm wrench tool for M6 wrench bolts Recheck if the 6 bolts are put into the right spots as shown...

Страница 73: ...e instruction carefully Remove the prop paper or vinyl on the floor Take the height meter body out of the box and unwrap the body Push up the head of the height meter to the A arrow direction and push...

Страница 74: ...over to make the height meter body put into easily Put the height meter body in the body cover Note RS 232C connector at the bottom of the height meter body should be placed at the connector socket Pu...

Страница 75: ...the height meter body to the arrow Lift up the inner column to the end and pull down the fixing lever to the arrow and fix it Also move the fixing rack to the spot where the fixing lever is matched Fi...

Страница 76: ...76 Connect a RS 232C cable to the HEIGHT port on the back side of the device Connect it to the adapter and turn on the power...

Страница 77: ...check and manage the result data on the exclusive mobile device app via Bluetooth connection Components for Bluetooth Unscrew the bolts 2EA and cable grand 1EA with a driver Keep the separate bolts 2E...

Страница 78: ...the main body connecting cable to the reverse side of the antenna and fix the cable by screwing the bolts in with a driver Connect the unconnected side of the cable to EXTERNAL PORT on the back side o...

Страница 79: ...79 Fix the Bluetooth to the back side of the main body with the provided bracket using a driver The installation is completed by turning on the device Joint of bracket...

Страница 80: ...sure safe operation 1 Components for installing an ankle electrode 2 Installing an ankle electrode Turn off the power of the device and disconnect the power cable before installing an ankle electrode...

Страница 81: ...ale by using a driver Check the RS 232C port of the weight scale and ankle electrode Connect the RS 232C port of the ankle electrode to the weight scale as shown in the picture Ankle electrode RS 232C...

Страница 82: ...e with one hand and fix it on the scale firmly by using M12 bolt 10mm 6 angle wrench and M4 bolt 3mm 6 angle wrench After it try shaking the ankle electrode to check if the fixation is good or not M4...

Страница 83: ...83 Remove the protective vinyl and double faced sticker inside of the top cover Attached the top cover on the ankle electrode to the arrow direction in the picture...

Страница 84: ...84 Power on After finishing the installation connect the adapter and power cable and turn on the device Adapter connecting Socket...

Страница 85: ...h operation Pass Fail 2 Recorder Smooth operation with no abnormal sound Pass Fail Mainframe 3 Touch Screen Smooth operation Pass Fail Accessories 1 Power cord Smooth operation and removal Pass Fail E...

Страница 86: ...operation Pass Fail Mainframe 2 Recorder Smooth operation with no abnormal sound Pass Fail Accessories 1 Power cord Smooth operation and removal Pass Fail Electrical Check 1 Power supply Screen displa...

Страница 87: ...BC360E 20161124 Rev1 1 EUROPEAN REPRESENTATIVE VITAKO Sp z o o ul Stanis awa aryna 7c 02 593 Warszawa POLAND TEL 48 22 400 8000...

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