BP868F Blood Pressure Monitor OPERATING MANUAL 1 BP868F / UME-03 REV.7 CONTENTS Thank you very much for your purchasing of AMPall product., This device is designed to measure blood pressure. Principle operating is oscillometric system that warps the cuff on the upper arm and press start button. Then, the air inflows from rolling pump and it make blood pressure measure and the build in IC reads the gauge and display blood pressure. Please read this operating manual carefully before using the device. Keep the operating manual with the device all the time. The Warranty Card is included in this operating manual. Please keep the Warranty Card carefully with the device otherwise you may not get proper customer service. If it is difficult to understand the operating manual or if there is any problem using the device, contact our customer center or your retailer for detailed guidance. IFUs currently offered are only available in English, so if you require IFU in a country that uses a different language, IFU will be provided in that language. Thank you. Features The angle of the cuff is designed to keep a patient in a comfortable posture when the patient places their arm into the cuff. All functions including the ideal tightening pressure of the air cuff and the pressurization of the fuzzy function are automated for user convenience. The audio guidance makes the patient measure pulse, and blood pressure easily, and troubles are notified as the audio guidance as well. Other than displaying the systolic, diastolic, average blood pressure, and pulse rate, the device operates with the COIN BOX. After finishing the measurement, measuring result with current date and time are printed out automatically. Auto-cutting printer is also available. (Optional – User has to notice about auto-cutting printer when places an order.) The blood pressure is displayed on the rear side of the device as well. It makes both of an operator and a patient can check the data at the same time. (Optional) With this blood pressure monitor, user can compare its analyzed data with other kinds of blood pressure measuring device, such as mercury blood pressure monitor or precision pressure gauge. BP868 has emergency stop system. In the emergency situation, please press stop button. Then, the air in cuff emit. It make easily remove the arm form cuff. It is easy to move the device with its handle on the side of the device. 2 BP868F / UME-03 REV.7 CONTENTS This blood pressure monitor can recognize troubles and errors by itself and notice it with audio guidance. [ e.g. ] 1. “Measuring again. Do not talk or move.” 2. “You pressed the wrong button.” 3. “Please insert the paper.” 4. “Please check the cuff.” 3 BP868F / UME-03 REV.7 CONTENTS 1. Intended of use 2. Cautions for Safety 3. Approval 4. Symbol 5. Description of Each Panel 1) Front 2) Printer …………………………... 5 …………………………... 5~7 …………………………... 8 …………………………... 9 ~ 10 …………………………... 11 …………………………... 11 …………………………... 12 3) Rear Side 4) Window Display 5) Components 6. Preparation 1) Connecting Power Cord 2)Replacing Fuse 3) Assemble Arm Rest 4) Paper Setting 5) Setting Initial Pressure Level …………………………... 13 …………………………... 14 …………………………... 15 …………………………... 16 …………………………... 16 …………………………... 16 …………………………... 17 …………………………... 17 …………………………... 18 6) Setting Date and Time 7)Number of Measurement 8)Recall the Store Data 7. Cautions During Measurement 8. How to Measure 9. Knowledge of Blood Pressure 10. Contents of Data 11. Troubleshooting 1) Display …………………………... 18 …………………………... 19 …………………………... 19 …………………………... 20 …………………………... 21 …………………………... 22 …………………………... 23 …………………………... 24 …………………………... 24 2) Voice 3)Emergency Management 4)Mean Separation from the Power Supply 5) Figure correction 12. Specifications 13. Service Contents 14. Information on EMC Warranty …………………………... 24 …………………………... 25 …………………………... 25 …………………………... 26 …………………………... 27 …………………………... 28 …………………………... 29 4 BP868F / UME-03 REV.7 INTENDED OF USE 1. Intended of use BP868F is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult(18 years of age and older) individual by using a non-invasive technique in which an inflatable cuff is wrapped around the arm. This product is intended to be used in public places such as hospitals, are available to patients except neonate or pregnant women. Following clinical benefits are expected: Prediction of cardiovascular disease associated with both systolic and diastolic blood pressure. Intended medical indication BP 868F is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the arm. This product is intended to be used in public places such as hospitals, are available to patients except neonate or pregnant women. Intended patient population Considerations : Requirement description Age: Adult, 18 years old or more Weight : Not relevant Health : Not relevant Nationality : Multiple Sex : Not relevant Patient state (arm circumference): 25 – 40 cm Intended part of the body or type of tissue applied to or interacted with Intended part: Not limited Condition: Intact skin Intended user profile (Operator Profile) Considerations : Requirement description Education Minimum : At least graduate of medical college Maximum : No maximum Knowledge Minimum : Read and understand 'westernized Arabic' numerals when written in Arial font - Can distinguish of human body - Understands hygiene Maximum : No maximum Language understanding Minimum : Local language Maximum : Understanding of manual that is writing in English Experience Minimum : Have license of radiologist or have to meet local regulation Maximum : No maximum Permissible impairments Minimum : Mild reading vision impairment or vision corrected to log MAR 0.2 - Average degree of aging-related short term memory impairment - Impaired by 40 % resulting in 60 % of normal hearing at 500 Hz to 2 kHz 5 BP868F / UME-03 REV.7 INTENDED OF USE Operating principle This device is designed to measure blood pressure. Principle operating is oscillometric system that warps the cuff on the upper arm and press start button. Then, the air inflows from rolling pump and it make blood pressure measure and the build in IC reads the gauge and display blood pressure. 2. Cautions for Safety Please read manual before use. The safety related warnings indicates in the following are for preventing unexpected danger or loss in advance by using the product safety and correctly. This is the symbol for calling attention to matters and operations that can cause danger. Take cautions and follow instructions in order to avoid danger. Warning Attention 1) If the user does not follow the instructions, the user can lose her or his life or receive a serious wound. If the user does not follow the instructions, the user can be wounded or face property damage. Warning ① During the installation – Do not disassemble or remodel the product. (Products disassembled at the user’s discretion are excluded from after sales service.) Please contact the manufacturer if the product needs to be repaired. When grounding the product, make sure not to come in contact with gas pipe, telephone line, and water pipe. ② About Power – Do not cut or modify the cord. Do not use damaged power or plug. It can be the reason of electric shock or fire. Do not pull plug with wet hands. It can be a risk of electric shock or burn. Make sure the power and voltage are 230VAC before installation.(If the power and voltage are over, there are dangerous of fire. To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth. ③ In Use – Do not spill liquid or put alien substances into the machine. Do not use the product when it is broken or malfunctioning. In case the water gets into the product, pull out the power plug immediately and call the service center. Do not use this product together with other medical instruments. When pressure is applied around the cuff, ME device that simultaneously perform monitoring functions on the same limb may temporarily lose their function. 6 BP868F / UME-03 REV.7 INTENDED OF USE Do not simultaneously contact the patient with areas where current exceeding the contact current may flow. Be sure to replace the power cord with the power off. Otherwise, there is a risk of electric shock. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the device, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. Attention 2) ① During the Installation – Do not use the product in an unstable place or a place where it can be adversely affected by dust, vibration and shock. Do not install or store the produce in a place that stores chemicals or generates gas. Do not store the product in the place where it can be adversely affected by air pressure, temperature, humidity, ventilation, and light. Use the designated parts only. Do not to position the product so that it is difficult to disconnect the power. ② About Power – This product can be plugged into ordinary power outlet. If the product is not going to be used for a long time, unplug the product. If there are dust and alien substances on the plug pin and the connecting part, wipe them off cleanly. Do not bend the power cord excessively. When pulling out the power cord, do not pull the cable but pull the plug. 7 BP868F / UME-03 REV.7 INTENDED OF USE After complete inspection, switch off the switch located on the back of the product ③ In Use – When you turn on the power, it will inspect the system for 3 seconds. Do not shock the product. Always check there is no trouble with the product overall while in use. Please press stop button in emergency situation. When cleaning the product, use soft cloth. Never use organic solvent (acetone, thinner, benzene, gasoline, etc.) or wet cloth. (However, in case the exterior of the product is contaminated seriously, use isopropyl alcohol and dry cloth to clean the product.) If you want to clean the inside of the cuff, please contact the manufacturer. If it makes strange sound, smell or smoke while in use unplug the machine immediately and call the service center. Measuring repeatedly can overstrain the user. Please wait at least 30 seconds after each measurement. In case of using the product after it has not been used for a long time, check the product for any abnormalities before use. If a user has interruption in blood circulation or blood related disease, please use the direction from medical doctor. Do not use for neonatal patient and pregnant patient. Do not use mobile phone close to device. It can be a reason of malfunction. This can be used by persons without disabilities who can perceive whether or not the product is operating. Do not use device other than measuring blood pressure. Do not pressure cuff over 300mm Hg. It is dangerous to decide and treat by user self without medical doctor’s direction. Please follow doctor’s treatment. This product is designed for measuring blood pressure, not for treatment The patient is an intended operator. When not in use for a long time, the coin battery inside must be removed Please note: if you are using this medical device have reason to believe that a serious incident has occurred, please report this to the dealer, manufacturer and your national authority 8 BP868F / UME-03 REV.7 APPROVAL 3. Approval 1) CE Mark - Approval mark for market in European communities (EC). 2) AMPall Co.Ltd passed performance and safety EMC test from KTL. 3) AMPall Co.Ltd also passed Manufacturing permit test and have permit of manufacturing of medical device. 4) Applicable Standard - IEC 60601-1:2005 - IEC 60601-1-2:2007 - IEC 60601-1-6:2010 - IEC 80601-2-30:2018 9 BP868F / UME-03 REV.7 SYSMBOL FOR USING 4. Symbol for using No. Description Symbol 1 Model Number. 2 UDI Code. 3 Refer to instructions for use 4 BF type protection applied. 5 Medical Device 6 Manufacturing Date and year 7 Manufacture information 8 Manufacturer’s EU representative information 9 Serial Number 10 CE Marking of conformity 11 Keep dry 10 Remark BP868F / UME-03 REV.7 SYSMBOL FOR USING 12 Fragile 13 This way up 14 Use no hooks 15 16 17 To indicate that transport package shall not be exposed to sunlight. Indicates the temperature limits to which the medical device can be safely exposed. Indicates the range of humidity to which the medical device can be safely exposed. Indicates the range of atmospheric pressure to 18 which the medical device can be safely exposed. 11 BP868F / UME-03 REV.7 DESCRIPTION OF EACH PANEL 5. Description of Each Panel 1) Front ① ⑥ ⑦ ② ③ ④ ⑤ ① Display Window Window displays all information and measuring data about blood pressure and pulse. ② START Button This button begins measurement. ③ STOP Button This button stops measurement. ④ Emergency Stop Button Press this button to release the cuff and stop the operation when the pressure is too high that it is hurting the arm or when the system is operating abnormally. ⑤ Paper Outlet The blood pressure information shown on the display panel after the measurement is printed and put out through this outlet. ⑥ Cuff Part (Applied Parts) Automatically tightens and releases the cuff while measuring the blood pressure. The Arm circumference range: 25 ~ 40 cm or less (brachial amidships) ⑦ Print Button 1) This button prints out the measured data. If the PRINT ON/OFF switch on the back is on, it will automatically print out the result before you press this button. 2) If you press this button when you are not measuring the blood pressure, it will load the previously measured values. To print the loaded data, press L/F button under the print cover. 12 BP868F / UME-03 REV.7 DESCRIPTION OF EACH PANEL 2) Printer BUTTON BUTTON ① SET Button Use this button to set date and time. It also changes the maximum pressure value (155 mmHg, 185 mmHg, 215 mmHg, 245 mmHg). ② L/F Button This button puts out the paper. This also changes numbers when setting date and time. 13 BP868F / UME-03 REV.7 DESCRIPTION OF EACH PANEL 3) Rear Side ⑨ ① ② ③ ④ ⑤ ⑥ ⑦ ⑧ ① Inspection Valve This is connected to mercury blood pressure monitor and precise pressure gauge to check the accuracy of the pressure. ② RS232C/COIN CONNECTOR Use this to connect the machine to external units such as the machine. (OPTION) ③ Voice Volume Use this to adjust the volume or turn on/off the voice guidelines. ④ Printer ON/OFF Switch ON: When the blood pressure is measured, the result is automatically printed out. OFF: Press the print button on the front to print the results after measuring the blood pressure. ⑤ COIN ON/OFF Switch Turn on this switch when using the coin machine. This switch must be turned off if the coin machine is not installed. ⑥ Equipotentiality port It is a connection port to maintain the equipotential when used in the same place as other medical devices. Cable is not provided. Use a cable that meets the specifications below: - Cable within 2 m length - It is recommended to use a wire diameter of 0.75 mm (AWG20) or more. ⑦ Power Socket Connect the power cord here. ⑧ Power Switch Turn on or off the blood pressure monitor. ⑨ Rear Side Display Display systolic pressure, diastolic pressure, and pulse rate on the rear side. 14 BP868F / UME-03 REV.7 DESCRIPTION OF EACH PANEL 4) Window Display Front Window Display Diastolic Systolic Pulse Detection Time Measurement in Process Pulse Rate 15 BP868F / UME-03 REV.7 DESCRIPTION OF EACH PANEL 5) Components ① Printer Roll ② Power Cord This is the thermal paper for printing the result of blood pressure measurement. Length: 25M, Breadth: 57.5mm • Do not store the paper in the humid or hot place. • Store it in the dark and cool place and make sure it is not directly exposed to sunlight. • Make sure the paper is not contaminated by alien substances. This power cord supplies power to the blood pressure monitor. ③ 232C Cable (OPTION) This cable connects the computer and blood pressure monitor. Use this cable to transmit data from blood pressure monitor to computer and control the blood pressure monitor from the computer. ④ Arm Supporter ⑥ IFU (Instruction For Use) ⑤ Coin Box(Option) 16 BP868F / UME-03 REV.7 CAUTIONS DURING MEASUREMENT 6. Preparation 1) Connecting Power Cord ① Connect the power cord to the AC power connector of the blood pressure monitor. ② Connect the grounding cable to the grounding terminal. [Attention] Do not connect the grounding line of the blood pressure monitor to gas pipe, telephone line, and water pipe. It is very dangerous. 2) Replacing Fuse If it does not display anything after you connect the power cord to the main unit, plug it to the outlet, and turn on the power, check the fuse first. Using regular screwdriver, remove the fuse above the power connector on the back of the blood pressure monitor, and check the wire inside the fuse is broken. If the wire is broken, replace it as follows. Inside the black fuse holder, there is an extra fuse. Remove the broken fuse and replace it with the new fuse. Extra Fuse Fuse in Use [Fuse Holder] 17 BP868F / UME-03 REV.7 CAUTIONS DURING MEASUREMENT 3) Assemble Arm Rest For better and more accurate blood pressure measurement, mount the arm rest supplied with the machine. 1. A : Prepare the Arm Rest. 2. B ,C : Combine BP868F and Arm Rest as shown in the photo. 3. D : Check BP868F and Arm Rest for good coupling. 18 BP868F / UME-03 REV.7 CAUTIONS DURING MEASUREMENT 4) Paper Setting Set the paper in the setup mode as in the picture on the right. To enter the setup mode, press the STOP button. 1) While the power is on, press the printer cover indicated area on the [Fig 1] to open the printer cover. 2) Pull up the lever on the left. [Fig 3] 3) Place the beginning of the roll into B as in Fig 3. Make sure the data is printed on the outer surface of the roll. 4) Press L/F button repeatedly until the paper comes out through C. [Fig 4] 5) In case the paper is tiled or leaned to one side, set the paper again. 6) When the paper comes out through C, put the shaft into the roll and put it in place. [Fig 5] 7) Pull down the lever. 8) Put the beginning of the recording paper into the groove of the cover to pull it toward the outside 9) Place the cover and close. [Fig 5] <Attention> • When you pull out the paper, pull up the lever first. • If you do not pull down the lever, it will not print. • Use thermal printing paper only (Length: 25 m, Breadth: 57.5 mm). • Make sure the paper is clean and not crumpled. • Do not pull the paper while printing. • Store the paper in a well ventilated and dark place. 5) Setting Initial Pressure Level Press L/F button to change initial pressure level to 155mmHg, 185mmHg, 215mmHg, 245mmHg and press SET button to set the pressure. If you do not need additional settings, press the STOP button. If you need to make additional settings such as date and time, press the SET button. 6) Setting Date and Time Turn on the power. Start setting the date and time in the setup mode. Enter the setup mode. •Open the print cover. •Set date and time in the order of Year→Month→Date→Hour→Minute. Setting Year ① Press the SET button under the print cover and the 3rd digit of the Year will flicker. ② Press L/F button. Each time you press the button, the number will change from 0~9. ③ If reach the number you want, press SET button to set the value. The first two digits of the Year will automatically change to 19 or 20 according to the digits you set. ④ When you press SET button, the 4th digit will begin to flicker. Press L/F button to select the appropriate value and press SET 19 BP868F / UME-03 REV.7 CAUTIONS DURING MEASUREMENT button to set. (Note: The maximum value that can be set for the Year is 2099.) Setting Month and Date ① When you set the Year, the ‘Month· Date Setting’screen will appear automatically. Press L/F button repeatedly to switch numbers from 1~12, each representing the month. When you reach the number you want, press SET button to set. ② When you press SET button, the “Date” will start to flicker. When you press L/F button, it will switch numbers from 0 to 3, and press SET button to set the number you want. Select the second digit of the date with L/F button and press SET button to set. Setting Time ① When the month and date are set, the ‘Time Setting’screen will appear. Press L/F button to set the number from 1~12 and press SET button to set. Check AM or PM. ② The “Minute” will flicker automatically. Select the first digit of the minute using L/F button and press SET button to set. Select the second digit of the Minute with L/F button and press SET button to set. <Attention> When you press STOP button while setting, the values will not be stored. When you turn off the power, the date and time values will remain for 60 days. However the time data can change if it is not used for a long time (more than 60 days). 7) Number of Measurement After you set the time, it will display the total number of use. The example on the right indicates that it was used 135,789 times to measure blood pressure. 135 789 8) Recall the Stored Data You can see 5 previous measurements (including systolic and diastolic pressures and pulse rate) with the device. The device stores measured data whether it is on or off. When you proceed to new measurement, the oldest measurement data will be erased and the new measurement will be stored. To recall the stored data, ① Press the “PRINT” button while you are not measuring the blood pressure. Recent measurement will be appeared. ② Every time you press the “PRINT button”, the window will display the stored data in order up 5 measurements. ③ To print the values, press “L/F” button under the print cover. 20 BP868F / UME-03 REV.7 CAUTIONS DURING MEASUREMENT 9) COIN Box - Connect the cables to the RS232C connector on the BP868F and coin box as shown. 7. Cautions During Measurement Directions for measuring dairy stable blood pressure - Sit in comfortable position during measurement. - Do not measure while standing and crossing legs. - Close feet against bottom during measurement. - Stand sack and arms in stable position - Before measuring the blood pressure, adjust the height of the stool so that the level of the heart comes to the level of the elbow when seated. Before measuring, calm down and relax for 5 minutes without moving. Do not talk or move while measuring. Take off heavy jacket when measuring. It can be automatic re-pressure cause of lack of pressure. (limit: 1 time) When you place your arm, push it all the way to place your arm on the arm rest. Any blood pressure reading can be affected by the measurement site, the position of the patient(standing, sitting, lying down), exercise, or the patient’s physiologic condition. Avoid exercise, food, smoking and cold before measuring. If you want to stop measuring or feel your arm is hurting, press the Emergency Stop button. 21 BP868F / UME-03 REV.7 CAUTIONS DURING MEASUREMENT Do not roll up the sleeve to the area of the arm that is measured. The blood pressure may be incorrectly measured. Do not place another part of the body in the cuff. Do not measure while the print cover is not in place. Too frequent measurements can cause injury to the patient due to blood flow interference. Please measure blood pressure after disappear congestion. – If pressure arm, fingertips of blood vessel can be stop. For disappearing congestion, remove arm from cuff. Hand up and grasped and straitening 15 times. Do not roll up sleeve on measuring part. It might affect on measuring accuracy. If measure on injured part, it will be worse. The cuff and its pressurization on any limb where intravascular access or therapy, or and arteriovenous(A-V) shunt, is present because of temporary interference to blood flow and could result in injury to the patient Do not measure after breast surgery. This device does not make damage on the circulation of blood. The following factors can affect the performance of sphygmomanometers and blood pressure readings. : common arrhythmias such as atrial or ventricular premature beats or atrial fibrillation, arterial sclerosis, poor perfusion, diabetes, age, pregnancy, pre-eclampsia, renal diseases, patient motion, trembling, shivering. 8. How to Measure ① Turn on the power. ② Place the right arm into the cuff. Adjust the stool height so that the level of heart comes to the level of elbow and make sure your palm is facing the ceiling and put your arm all the way in and put it on the arm rest. ③ Press “START” button. MENT: “Measuring is started.” “Don’t speak or move, please.” The pressure is applied to the cuff automatically and the measurement will begin. ④ “Measurement in Process (MEASURE)” lamp will be lit when the measurement begins ⑤ After the measurement, the air will be exhausted automatically and the cuff will release the arm. The blood pressure and pulse rate will be displayed. MENT: “Measuring is finished. Your blood pressure is ___ to ___. ” ⑥ Remove your arm from the cuff. 22 BP868F / UME-03 REV.7 KNOWLEDGE OF BLOOD PRESSURE ⑦ If the PRINT Switch on the back of the machine is ON, the results will be printed out automatically and if it is OFF, the voice will say, “If you want to print the results, please press the PRINT button.” Press PRINT button to print out the result if necessary. ⑨ The results will be printed out. When the paper is out, cut the paper. ⑩ MENT : “Thank you, for using” 23 BP868F / UME-03 REV.7 CONTENTS OF DATA 9. Knowledge of Blood Pressure Blood pressure means the pressure of blood push the blood vessel during heart beat. Commonly says “120/ 80”. 120 is the measure of pressure exerted by circulating upon the walls of blood vessels on systolic. 80 is the measure of blood vessel on diastolic. Diagnosis of high blood pressure High blood pressure means that measure of blood pressure is higher than normal. WHO, European Society of Cardiology and JNC 7 give the standard of diagnosis of high blood pressure. Commonly JNC7 is used. The below table is the standard of diagnosis of high blood pressure by JNC7. Level of high blood pressure Systolic Diastolic Normal Under 120 Under 80 Pre-hypertension High stage1 High satge2 120 ~ 139 140 ~ 159 Over 160 80 ~ 89 90 ~ 99 Over 100 Reason of high blood pressure The reasons of high blood pressure are high cholesterol, smoking, diabetes, lack of exercise, over weight, which are possible to control risk factors and age, gender and family history which are impossible to control. If you have high blood pressure, need to improve life style to decrease circumstance factor and take a medicine to decrease blood pressure into normal range. 24 BP868F / UME-03 REV.7 CONTENTS OF DATA 10. Contents of Data • SYSTOLIC • DIASTOLIC • MEAN • PULSE/min 01:33 PM April 10, 2007 Systolic ····· 128mmHg Diastolic ····· 062mmHg Mean ······ 084mmHg Pulse/min ···· 082/ min *World Health Organization (WHO) Blood Pressure Categorization Graph* 25 BP868F / UME-03 REV.7 TROUBLE SHOOTING 11. Trouble shooting 1) Display Error Cause Solutions EE2 Pulse is too weak to measure Calm down and relax and measure again. Take off thick jacket. If the pulse is too weak to even hear it through the stethoscope, it is difficult to measure the blood pressure. EE3 Blood pressure and Pulse are too irregular to measure (off reference) Calm down and measure again EE4 Moved when measuring the pulse Do not move or talk when measuring the pulse 2) Voice Guidance Voice “Measuring again. Do not speak or move.” “Please insert the paper.” “You pressed the wrong button.” “Please check the cuff.” Cause This happens when the patient moves while measuring the pulse and it will automatically begin to measure again. However, it will stop in case this happens twice. There is no paper. (When the red line appears on the side of the paper, change the paper) Wrong button is pressed. The patient pressed the START button without placing the arm inside the cuff or the air is slightly leaking from inside. (Repair is required) 26 BP868F / UME-03 REV.7 TROUBLE SHOOTING 3) Emergency Management Problems Nothing display is shown Solutions on the • Check the power cord. • Check the fuse. (Refer to page 2-1 when replacing the fuse.) Pressure is not applied • Check the mercury blood pressure monitor tube (CAL terminal). • Check whether there are alien substances between cuff and cuff cover. Voice is not heard • Check whether the voice switch volume on the back is ON. Printer a. Nothing is printed • Check the surface and direction of the thermal paper. • Check whether the lever on the left is pressed down. Use the designated thermal paper. • Open the printer cover and check whether the paper is stuck. • Check whether the printer switch on the back is On. b. Paper is not out c. It does not automatically Cuff is tight loosened and The measurements abnormal print is not • Press the Emergency Stop switch on the front side. • Check whether there are alien substances between cuff and cuff cover. are • Check whether the installation location and peripheral environment are appropriate for measurement. (Temperature 10℃~40℃, humidity 95% or less) Check whether the measuring posture is appropriate. When the button is pressed, the beep sound is heard but it does not operate • Check whether the coin is on or off. Turn off the coin machine if it is not in use. ※ All device repairs must be performed by the manufacturer. For other troubles, please contact the manufacturer’s Customer Service Center directly or contact your retailer. 4) Means separation from the power supply Power cord - Disconnect the power cord to the AC power. 27 BP868F / UME-03 REV.7 TROUBLE SHOOTING 5) Figure correction Caution : Please check the unit with stethoscope before doing this. Get into TEST MODE :Press SET button(Maximum pressure value is displayed.)-> Press Print button 3 times -> Press L/F twice -> Press SET button -> Press L/F button twice -> Press SET button ->Press L/F button once.(Display should show “0000” in the window.) Get into TEST MODE. Get into “0”by press L/F button. Cuff is wrapped automatically. At this time there should be such an artificial arm to be measured. Connect Mercury BP monitor with CAL port and inflate cuff with Air chamber on Mercury BP monitor. Pressure on BP868 and Mercury BP monitor will go up together. Inflate about 150 to 200mmHg and compare both monitor. At time, compare both pressure when pressure decreases slowly so both monitor can be checked easily. Different pressure between BP868 with Mercury BP monitor should be within ±6mmHg(Error range of Mercury BP monitor is ±4mmHg, Error range of BP868 is ±2mmHg). If difference of pressure is out of range, try Method 0 as below. When Mercury BP monitor is connected with CAL port on BP868F, there should be no leakage of pressure on Air chamber and CAL port. Method 0 : Connect the External pressure equipment(BP Pump to FLUKE) to the CAL terminal of the blood pressure monitor. After pressurizing more than 300mmHg with the BP pump, press the SET key when the BP pump indicates 300mmHg. (Execution step by step 300, 5, 0mmHg) The pressure constant is displayed on the FND window where the time is displayed. The pressure error can be compensated for by adjusting this value. Use the LF /PRINT button to set the time constant to the pressure value indicated by the BP Pump for the part where there is an error. If you press the SET button, the data is saved and the mode ends. but Pressing the start/end bouton exits the mode without saving data. Method 1: Get into TEST MODE -> Adjust number 19 by pressing SET button, get into mode by pressing L/F button -> Basic value is 70, it can be adjusted by pressing L/F button.-> When the measuring value is high, adjust number less than 70, when the measuring value is low, adjust 28 BP868F / UME-03 REV.7 TROUBLE SHOOTING number more than 70. -> Save the value by pressing SET button -> Get out of MODE by pressing START/STOP button. -> Measure blood pressure again. Method 2: Get into TEST MODE -> Adjust 14 by pressing SET button, get into the mode by pressing L/F button. -> Basic value is “0”, it can be adjusted by pressing L/F & SET button -> When Systolic is high, adjust SyS value at ‘-‘as much as it high, when it is low, adjust SyS value at’+’ as much as it low. -> When Diastolic is high, adjust Dia value at ‘-’ as much as it high, when it is low, adjust Dia value at ‘+’ as much as it low. -> Save the value by pressing START/STOP button. -> Get out of MODE by pressing START/STOP button -> Measure blood pressure again. * This mode shall not be available in NORMAL USE, But restricted to SERVICE PERSONNEL. * The BP868F must check the pressure at least once a year. 29 BP868F / UME-03 REV.7 SPECIFICATION 12. Specification Model Name BP868F Measurement Method Oscillometric method Exhaustion Method Automatic exhaustion by micro controller Pressure Detection Semiconductor strain gauge Display Method LCD or FND (7-Segment) Measurement Scope Pressure: 30~300mmHg Pulse: 30~200/min Minimum Measurement Unit 1mmHg Precision Pressure: ±2mmHg Pulse: ±3% Cuff Operating Method Belt operation by micro controller Pressurizing Time Approximately 10 seconds Measuring Time Approximately 30 seconds Print Thermal high speed printer (option: auto-cutting) Power AC230V (Fuse : F 2.0AL, 250VAC) Frequency 50 Hz Classification Class 1 Type of protection Type BF Degree of protection IPX0 Communication Connectible to coin machine (option: RS232C cable) Emergency Stop Stops by micro processor Voice Support Provides voice guidelines Reads blood pressure value after measurement as well as the error message Power Consumption 50VA Operation Scope Temperature +10℃~+40℃, humidity 95% or less, pressure 70~106Kpa Storing Condition Temperature –5℃~+50℃, humidity 85% or less, pressure 50~106Kpa Dimension 453 (W)×340(D)×306(H) Weight Approximately 8.6kg Components 1 power cord, thermal paper roll, arm rest, user manual Options Customer management program, communication cable, auto-cutting protection cover Software version B8M0101K:MAIN, B8I0101K:IO, B8D0101K:SUB 30 BP868F / UME-03 REV.7 Information on EMC 13. Service Contents In case any trouble is found while it was used under normal condition during the warranty period or in case any manufacturing defect is found, contact our customer service center for free repair. Services will be charged in the following cases regardless of the warranty period. ① The warranty period (1 year) is expired ② The trouble was caused by negligence of the user ③ The contents of the product are modified or damaged by the user ④ No warranty certificate ⑤ Trouble due to natural disasters ⑥ The person other than the technician from our service center repaired or remodeled the product and the trouble is found The warranty certificate is not reissued. Please keep it importantly. You must present the warranty when requesting for repair. ►Parts can be replaced or functions can be changed in order to enhance product quality. ◄ 31 BP868F / UME-03 REV.7 Information on EMC 14. Information on EMC 14.1 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The EUT is intended for use in the electromagnetic environment specified below. The customer or the user of the EUT should assure that it is used in such an environment. Emission test RF Emissions CISPR 11 RF Emissions CISPR 11 Compliance Electromagnetic environment - Guidance The EUT uses RF energy only for its internal function. Group 1 Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment Class A The EUT is suitable for use in ail establishments, including Harmonic emissions domestic establishments and those directly connected to Class A IEC 61000-3-2 the public low-voltage power supply network that supplies buildings used for domestic purposes Voltage fluctuations / Flicker emissions Complies IEC 61000-3-3 32 BP868F / UME-03 REV.7 Information on EMC 14.2 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The EUT is intended for use in the electromagnetic environment specified below. The customer or the user of the EUT should assure that it is used in such an environment. Immunity test IEC 60601 Test level Compliance level Electromagnetic environment Guidance Floors should be wood, concrete Electrostatic discharge (ESD) IEC 61000-4-2 ±(2,4,6)kV Contact ±(2,4,6)kV Contact ±(2,4,8)kV air ±(2,4,8)kV air or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. AC Mains (Line to AC Mains (Line to Surge Line): ± (0.5, 1) kV Line): ± (0.5, 1) kV IEC 61000-4-5 (Line to Earth): ± (Line to Earth): ± (0.5, 1,2) kV (0.5, 1,2) kV immunity interruptions IEC 61000-4-11 hospital environment. should be at levels characteristic 3 A/m 3 A/m of a typical location in a typical commercial or hospital IEC 61000-4-8 Voltage dips, short that of a typical commercial or Power frequency magnetic fields Power frequency magnetic field Mains power quality should be environment. <5% Uт <5% Uт (>95% dip in Uт) (>95% dip in Uт) Mains power quality should be for 0.5cycle for 0.5cycle that of a typical commercial or 40% Uт 40% Uт hospital environment. If the user (60% dip in Uт ) (60% dip in Uт) of the EUT image intensifier for 5 cycle for 5 cycle requires continued operation 70% Uт 70% Uт during power mains (30% dip in Uт) (30% dip in Uт) interruptions, it is recommended for 25 cycle for 25 cycle that the EUT image intensifier be <5% Uт <5% Uт powered from an uninterruptible (<95% dip in Uт ) (<95% dip in Uт) power supply or a battery. for 5 s for 5 s NOTE Uт is the A.C. Mains voltage prior to application of the test level. 33 BP868F / UME-03 REV.7 Information on EMC 14.3 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The EUT is intended for use in the electromagnetic environment specified below. The customer or the user of the EUT should assure that it is used in such an environment. Immunity test IEC 60601 Compliance Electromagnetic environment - Test level level Guidance Portable and mobile RF communications equipment should be used no closer to any part of the EUT, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3 3 Vrms 3 Vrms 150 kHz to 150 kHz to 80MHz 80MHz 3 V/m 3 V/m 80 MHz to 80MHz to 2.5GHz 2.5GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as deter-mined by an electromagnetic site survey, a should be less than the compliance level in each frequency range. b Interference may occur in the vicinity of 34 BP868F / UME-03 REV.7 Information on EMC equipment marked with the following symbol : NOTE 1) At 80MHz and 800MHz, the higher frequency range applies. NOTE 2) These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption 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 considered. If the measured field strength in the location in which the EUT is used exceeds the applicable RF compliance level above, the EUT should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the EUT. b Over the frequency range 150kHz to 80MHz, field strengths should be less than [V1] V/m. 35 BP868F / UME-03 REV.7 Information on EMC 14.4 Recommended separation distances between portable and mobile RF communications equipment and the EUT There is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the EUT can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the EUT as recommended below, according to the maximum output power of the communications equipment. Separation distance according to frequency of transmitter [m] Rated maximum 80MHz to 800MHz to 800MHz 2.5GHz V1=3Vrms E1=3V/m E1=3V/m 0.01 0.116 0.1166 0.2333 0.1 0.368 0.3687 0.7378 1 1.166 1.1660 2.3333 10 3.687 3.6872 7.3785 100 11.660 11.6600 23.333 output power of 150kHz to 80MHz transmitter [W] 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 of the transmitter, where p is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1) At 80MHz and 800MHz, the separation distance for the higher frequency range applies. NOTE 2) These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. 36 BP868F / UME-03 REV.7 Information on EMC 14.5 Immunity and Compliance Level Immunity test IEC 60601 Test Level Conducted RF 3Vrms IEC 61000-4-6 150kHz to 80MHz Radiated RF 3Vrms IEC 61000-4-3 80MHz to 2.5GHz Actual Immunity Compliance Level Level 3Vrms 3Vrms 3V/m 3V/m 14.6 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The EUT is intended for use in the electromagnetic environment specified below. The customer or the user of the EUT should assure that it is used in such an environment. Immunity test IEC 60601 Compliance Electromagnetic environment - test level level Guidance The EUT must be used only in a shielded location with a minimum RF shielding effectiveness and, for each cable that Conducted RF IEC 61000-4-6 enters the shielded location with a 3 Vrms 3 Vrms 150 kHz to 150 kHz to 80MHz 80MHz minimum RF shielding effectiveness and, for each cable that enters the shielded location Field strengths outside the shielded location from fixed RF transmitters, as determined by an Radiated RF IEC 61000-4-3 electromagnetic site survey, should be less 3 V/m 3 V/m 80 MHz to 80MHz to 2.5GHz 2.5GHz than 3V/m.a Interference may occur in the vicinity of equipment marked with the following symbol: 37 BP868F / UME-03 REV.7 Information on EMC NOTE 1) These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. NOTE 2) It is essential that the actual shielding effectiveness and filter attenuation of the shielded location be verified to assure that they meet the minimum specification. 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 considered. If the measured field strength outside the shielded location in which the EUT is used exceeds 3V/m, the EUT should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as relocating the EUT or using a shielded location with a higher RF shielding effectiveness and filter attenuation. 38 BP868F / UME-03 REV.7 Information on EMC Warranty Card Thank you for your purchasing for AMPall product. The warranty period of BP868F is valid from the purchasing date. Please notice the purchasing date on the warranty card and keep this Warranty Card with the device all the time to get full customer service. Product Name Artificial Intelligence Blood Pressure Monitor Model Name □ BP868F Manufacturing Date Warranty Period 1 year Purchasing Date / / Name: (year/ month/ date) Tel.: Customer Add.: Name: Tel.: Retailer Add.: Repairing Record Date ☆ Contents of Repair Confirmation Please show this Warranty Card when you request repairing service. 3F. Annex Hankook Junja Hyeopdong B/D, 114, Gasan Digital 2-ro, Geumcheon-Gu, Seoul, 08506, Korea TEL : +82-2-858-2839~41 / FAX : +82-505-350-2442 E-mail : ampall@ampall.com / Website: www.ampall.com 39 BP868F / UME-03 REV.7 Information on EMC ■ This is a medical equipment ■ ▪ Product Name: Blood Pressure Monitor (BP868F) ▪ Manufacturer: AMPall Co., Ltd 3F Annex Hankook Junja Hyeopdong B/D, 114, Gasan Digital 2-ro, Geumcheon-Gu, Seoul, 08506, Korea Tel.+82-2-858-2839~41, Fax.+82-505-350-2442 http://www.ampall.com ▪ EC Representative : AR Experts B.V. Amerlandseweg 7, 3621 ZC Breukelen, The Netherlands TEL: +31 (0)88 995 1333 E-mail: info@ar-experts.eu ▪ Protection against Electric Shock and Degree of Protection: First Class Equipment, Equipment Type BF ▪ Rated: 1-Phase AC230V 50Hz ▪ Power Consumed: 50VA ▪ Fuse: F 2.0AL, 250VAC ▪ Precision and Measurement Range: Pressure (30~300mmHg, ±2mmHg), Pulse (30~200/min., ±3%) ▪ Operating Method and Cautions: Refer to the User Manual ▪ Purpose of Use: Measurement of blood pressure and pulse rate ▪ Manufacture Permit: No. 2187 ▪ Item Permit: No. 01-431 ▪ Weight: 8.6Kg (main unit) 40 BP868F / UME-03 REV.7