Grandway Technology MD20XYSERIES Digital Automatic Blood Pressure Monitor User Manual MD2020 Manual Lab

Grandway Technology (Shenzhen) Limited Digital Automatic Blood Pressure Monitor MD2020 Manual Lab

User Manual

DIGITAL AUTOMATICBLOOD PRESSURE MONITORUSER MANUALMODEL : MD2020/MD2030/MD2060/MD2070/ MD2021/MD2031/MD2061/MD2071/MD2080
INTRODUCTIONThank you for purchasing this Blood Pressure Meter. This fully automatic instrument measures blood pressure and pulse rate promptly and easily. This device is intended for the non-invasive measurement of systolic and diastolic arterial blood pressure and pulse rate in adults (age 15 and above). Please read this manual thoroughly before use. Contact your physician if you have any query about your blood pressure.This device conforms to the European Directive 93/42 EEC for Medical Products. This is made evident by the CE mark of conformity accompanied by the reference number of the designated authority.This device complies with EN1060 standard relating to non-invasive blood pressure monitors Part 1/1995 : General requirements and Part 3/1997 : Additional requirements for electromechanical blood pressure measuring systems. This completely automatic instrument quickly measures your blood pressure and pulse rate and displays on a large digital panel. This unit uses the oscillometric method of blood pressure measurement. This means the monitor detects your blood's movement through your brachial artery and converts the movements into a digital reading. An oscillometric monitor does not need a stethoscope so the monitor is simple to use. The cuff fills with air the push of a button and automatically deflates when the measurement is complete.The arm cuff has been treated as Applied Part (clause 3.8 in IEC 60601-1:2005) PRECAUTIONS• This device will detect the atmospheric pressure first after power on each time, so atmospheric pressure is not a factor at this monitor.• Precision components are used in the construction of this device. Extremes in temperature, humidity, direct sunlight, shock or dust should be avoided.• To share the cuff, it need to disinfect by UV light before using and user should cover the LCD screen of the device from the UV light.• If no UV light for disinfection, a mild soap and water (and drying afterwards) to be used for cleaning the surface of the cuff before using. Make sure that no liquid enters into the bladder inside the cuff.• Avoid folding the cuff or storing the hose tightly twisted for long periods, as such treatment may shorten the life of the components.• The device and cuff are not water-resistant. Prevent rain, sweat and water from soiling the device and cuff.• Measurements may be distorted if the device is used close to a television, microwave oven, cellular telephone, X-ray or other devices with strong electrical fields.• Used equipment, parts and batteries are not treated as ordinary household waste, and must be disposed of according to the applicable local regulations. Do not use the equipment where flammable gas (such as anesthetic gas, oxygen or hydrogen) or flammable liquid (such as alcohol) are present. User should not make any clinical decision based on the device’s results alone, unless he/she consults with a medical doctor.• WARNING: No use-serviceable parts inside, before servicing to authorized representation or manufacturer!• WARNING: No modification of this equipment is allowed MAINTENANCEDo not open the device. It uses delicate electrical components and an intricate air unit that could be damaged. If you cannot fix the problem using the troubleshooting instructions, request service from your dealer.The device was designed and manufactured for a long service life. However it is generally recommended to have the monitor inspected every 2 years, to ensure proper functioning and accuracy. Please contact your dealer for maintenance.Avoid dropping the device. If the device is dropped, especially on a hard surface, and the user suspects damage, please contact your dealer for inspection. 1
INSTALL / CHANGE BATTERIES1. Pull out the battery cover on the back side of the unit as directed.2. Battery door will pop up instantly. Remove the used batteries and insert new ones as shown. Make sure the polarities (+) and (-) are correct.3. Push battery cover down to close it.4. Use only R6P, LR6 or AA alkaline batteries,do not use rechargeable batteries.5. Only same type batteries are allowed to usetogether. CAUTION• Insert the batteries as shown in the battery compartment. If not, the device will not work or even be damaged.• When [ ] blinks and "E6" appears in the display, replace all batteries with new ones. Do not mix old and new batteries. It may shorten the battery life, or cause the device to malfunction.• [ ] appears when batteries are new. When battery power becames weak, [ ] and "E6" will appear on display.• Battery life varies with the ambient temperature and may be shorter at low temperature.• Remove the batteries if the device is not to be used for a long time. Batteries may leak and cause a malfunction.• If the battery leaks: - Do not allow the leaking fluid to come in contact with skin or clothing. If already in contact, flush the affected are immediately with clean water and seek medical advice. - Do not allow the leaking fluid to come in contact with eyes. If already in contact, DO NOT rub; rinse with clean water immediately and seek medical advice. - Take extra precautions to keep a leaking battery away from fire as there is a danger of ignition or explosion.To open:Pull out from hereTo close:Insert the battery cover tothe 3 lock first, and then pushdown to close it 2
USE OPTIONAL AC ADAPTOR (Accessory item sold separately) 1. When optional AC adaptor should comply with the requirement of IEC 60601-1:2005. Furthermore all configurations shall comply with the requirements for medical electrical systems (see IEC 60601-1-1 or clause 16 of the 3Ed. of IEC 60601-1, respectively). Anybody connecting additional equipment to medical electrical equipment configures a medical system and is therefore responsible that the system complies with the requirements for medical electrical systems. Attention is drawn to the fact that local laws take priority over the above mentioned requirements. If in doubt, consult your local representative or the technical service department.2. When using AC power, use only the exclusive AC adapter that can be purchased from authorized dealers3. Insert the AC adapter cord into the jack on the right side of the monitor.4. Insert the AC adapter plug into the outlet.5. To remove the AC adapter, disconnect the adapter plug from the AC outlet first and then disconnect the cord from the monitor's jack. To avoid possible damage to the monitor, use only the exclusive AC adapter specified by authorized dealers. Other adapters may vary in output voltage and polarities.Note: The monitor is designed not to draw power from the batteries when the AC adapter is in use.Note: When optional AC adaptor used, such adaptor and the device consist a medical electrical system, and when need to isolate from supply mains, please pull out the plug of AC adaptor from outlets.Adapter technical features: (For Europe only: comply with the requirement of IEC 60601-1:2005)Input voltage: US: 110VAC/60Hz ; Europe: 230VAC/50HzOutput voltage: 6V 5%Max. output current: At least 600 mAOutput plug polarity: <+> innerExternal diameter: 5.5mm 0.1mmInternal diameter: 2.1mm 0.1mmLength: 11mm 0.3mm CONNECT THE AIR HOSEInsert the air connector plug into the air socket firmly. 3
PART IDENTIFICATIONButton Operations• Go to sleep mode Press button.• Recalling average data Press button.• Select between different users (User 1 / User 2 / User 3 / User 4) Press or buttonAir socket Start / StopButton IncreaseButtonDecreaseButtonMemoryButtonAir Connector PlugWHO IndicatorIndex MarkArm CuffAir HoseDisplayBattery DoorDC Jack4
DISPLAY READINGS5Date TimePressurizingUSERReleasing AirAverage ofPreviousMeasurementMemoryBluetoothBatteryIndicatorPulse RateDiastolic PressureSystolic PressureIrregular Heartbeat IndicatorSevere HypertensionModerate HypertensionMild HypertensionHigh NormalNormalOptimal
BEFORE MEASURE YOUR BLOOD PRESSURE• Sit down in a comfortable position. Place the arm to be used for the measurement on a table or other support so that the center of the cuff with be at the same height as your heart.• Relax for about five or ten minutes before taking a measurement. If you are excited or depressed by emotional stress, the measurement will reflect this pulse reading will usually be faster than normal.• Your blood pressure varies constantly, depending on what you are doing and what you have eaten. What you drink can have a very strong and rapid effect on your blood pressure.• This device bases its measurements on the heartbeat. If you have a very weak or irregular heartbeat, the device may have difficulty determining your blood pressure.• Should the device detect a condition that is abnormal, it will stop the measurement and display an error symbol.• This instrument is intended for use by adults only. Consult with your physician before using this device on a child. A child should not use this device unattended.6
TO APPLY ARM CUFF1.If the cuff is assembled correctly, the sewn hook material will be on the outside of the cuff loop and the metal D-ring will not touch your skin.2.Pass the end of the cuff furthest from the tubing through the metal D-ring to form a loop. The smooth cloth should be on the inside of the cuff loop.3.Put your left arm through the cuff loop. The bottom of the cuff should be approximately 1/2 inch above the elbow. The white artery marker on the cuff should lie over the brachial artery on the inside of the arm. Tube should run down center of arm even with the middle finger. 4.Pull the cuff so that the top and bottom edges are tightened evenly around your arm.5.When the cuff is positioned correctly, press the sewn hook material firmly against the pile side of the cuff.6.Make certain the cuff fits snugly around your arm. The cuff should make good contact with your skin.7.Sit in a chair with your feet flat on the floor and place your arm on a table so that the cuff is at the same level as your heart.8.Relax your arm and turn your palm upward.9.Be sure there are no kinks in the air tubing.NOTE: If the circumference around your arm is greater than 32 cm, you will need to use a large adult size cuff. The large adult cuff is an accessory item and it is sold separately.ATTENTION: Do not use cuff other than the original cuffs contained in this kit!1/2 inch7
TO SET CLOCKPress and hold [ ] button to enter clock setting mode1. "Year” will blink on display automatically2. Press / button to select year3. Press [ ] button to confirm and "Month" will blink4. Press / button to select month5. Press [ ] button to confirm and "Day" will blink6. Press / button to select day7. Press [ ] button to confirm and "Hour" will blink8. Press / button to adjust to desired hour9. Press [ ] button to confirm and "Minute" will blink10. Press / button to adjust to desired minute11. Press [ ] button to confirm and settings are done8
TO MEASURE YOUR BLOOD PRESSURE1. Place the cuff on the arm (preferably the left arm). Sit quietly during measurement.2. Press [ ] button to start. The deflation icon and measurement record number is displayed briefly. Then the cuff starts to inflate. It is normal for the cuff to feel very tight. The inflaction number is displayed during measurement.Note: If you wish to stop inflation at any time, press the [ ] button again.3. When inflation is complete, deflation starts automatically and the [ ] blinks, indicating that the measurement is in progress. Once the pulse is detected, the mark flashes with each pulse beat.4. When the measurement is complete, the systolic and diastolic pressure readings and pulse rate are displayed and stored. The cuff exhausts the remaining air and deflates completely.9Deflation for start measuring Record number and User ID are displayedInflation in progressMeasurement result shown[ ] icon blinks
WHO CLASSIFICATION INDICATOREach of the six segments of the bar indicator corresponds to the WHO blood pressure classification.WHO Classification Indicator: 10Severe HypertensionModerate HypertensionMild HypertensionHigh NormalNormalOptimal
Pressure Bar IndicatorThe indicator monitors the progress of pressure during measurement.11Pressurizing Releasing AirInflation in progressInflation complete Measurement in progress
TO USE THE MEMORY FUNCTIONThis monitor has a memory capable of storing 240 sets of readings for each user. Every time you complete the measurement, the monitor automatically stores blood pressure and pulse rate.Recalling the average data• Press [ ] button to enter the memory mode, the average blood pressure on last 3 measurements is displayed.• Press [ ] to view average data for AM period• Press [ ] one more time to view average data for PM periodRecalling the previous measurement record• Press [ ] button to enter the memory mode, the average blood pressure on last 3 measurements is displayed.• Press [ ] to view the previous measuremnt record12Press [ ] Press [ ] Press [ ] again
DELETING ALL DATA STORED IN MEMORYDeleting all data stored in memory• Press [ ] to go into average data display.• Press and hold [ ] and [ ] for 2 seconds to delete all memory records.13All memories clearedPress [ ]Press and hold [ ] and [ ] at the same time
BLUETOOTH CONNECTIONThis monitor works with iPod touch, iPhone or iPad by Bluetooth connection. Please installapplication (APP) - BPM Smart to your devices from the App Store before you start.Transfer data from your monitor to your smartphone or tablet devices • Press any key to start up the monitor. Press [ ] or [ ] to select the target user profile and press [ ] or [ ] to confirm your selection.• Press and hold [ ] and [ ] buttons to turn on the bluetooth connection. The bluetooth icon [ ] is flashing.• Launch the app. and go to the data transfer section. Press the “Connect” button. The data transfer icon is rotating.• When connected, the bluetooth icon [ ] on the monitor will stop flashing. The data transfer icon in the app. will stop rotating and change to blue.• Press [ ] button on the monitor to send data to the app. and the data transfer icon is rotating while the app. is receiving data.• Once the data transfer icon is stop rotating, the date transfer process is finished. 14Data Transfer Data Transfer IconConnect Button
WHAT IS AN IRREGULAR HEARTBEAT?This blood pressure monitor provides a blood pressure and pulse rate measurement even when an irregular heartbeat occurs. An irregular heartbeat is defined as a heartbeat that varies by 25% from the average of all heartbeats during the blood pressure measurement. It is important that you are relaxed, remain still and do not talk during measurements.Note: We recommend contacting your physician if you see this [ ] indicator frequently. ABOUT BLOOD PRESSUREWhat Is Blood Pressure?Blood pressure is the force exerted by blood against the walls of the arteries. Systolic pressure occurs when the heart contracts. Diastolic pressure occurs when the heart expands. Blood pressure is measured in millimeters of mercury (mmHg). One’s natural blood pressure is represented by the fundamental pressure, which is measured first thing in the morning while one is still at rest and before eating.What Is Hypertension And How Is It Controlled?Hypertension, an abnormally high arterial blood pressure, if left unattended, can cause many health problems including stroke and heart attack. Hypertension can be controlled by altering one’s lifestyle, avoiding stress, and with medication under a doctor’s supervision. To prevent hypertension or to keep it under control:• Do not smoke• Exercise regularly• Reduce salt and fat intake• Have regular physical checkups• Maintain proper weight15
Why Measure Blood Pressure At Home?Blood pressure measured at a clinic or doctor’s office may cause apprehension and can produce an elevated reading, 25 to 30 mmHg higher than that measured at home. Home measurement reduces the effects of outside influences on blood pressure readings, supplements the doctor’s readings and provides a more accurate, complete blood pressure history.WHO Blood Pressure ClassificationStandards to assess high blood pressure, without regard to age, have been established by the World Health Organization (WHO), as shown in the chart below.Reference Material: Journal of Hypertension 1999, Vol 17 No.2mmHg11010510095908580Diastolic blood pressure120 130 140 150 160 170 180 Systolic blood pressure mmHgGrade 3 hypertension (severe)Grade 2 hypertension (moderate)Grade 1 hypertension (mild)High-normalNormalOptimal16
TROUBLE SHOOTINGNothing appears in the display, even when the power is turned onBatteries are drained Replace all batteries with new onesBattery polarities are not in the correct positionRe-install the batteries with their negative and positive ends matching their indicated in the battery compartmentLoose in plug or contact with outlet (IF AC adaptor is used)Check the wiring to make sure plug & outlet are properly securedERROR code 1(E1)appearsThe cuff position is not fastened properlyFasten the cuff correctlyThe cuff position is not correct Sit comfortably and still. Ensure that the cuff is the same level as the heartERROR code 2(E2)appearsYou moved your arm or body during measurementMake sure you remain very still and quiet during the measurement17
TROUBLE SHOOTINGERROR code 3(E3)appearsThe unit does not measureCheck whether tube connection of the cuff is secured to the unit properlyERROR code 4(E4)appearsThe cuff may not be appliedIf you have a very weak or irregular heart beat, the device may have difficultly in determining your blood pressureThere is a measuring Error Sit comfortably and still. Fasten the cuff again carefullyERROR code 5(E5)appearsCuff over inflated The measurement range is over300 mmHg. It is recommended tosee doctor as soon as possible.The monitor keepsreinflatingCircuit locked Remove and reinsert the batteriesand then proceed to take measurement again.ERROR code 6(E6)appearsLow battery The battery power is too low to function. Replace the batteries withnew ones.18
SPECIFICATIONDisplay : LCD DisplayMeasurement Range : Pressure : 30-250 mmHg Pulse : 40-180 beats/minuteAccuracy : Pressure : +/-3 mmHg or 2% of the reading Pulse : +/-5% of readingMeasurement Method : Non-invasive, Oscillometric methodPower Source : 4 x"AA" Alkaline batteries, Optional AC Adaptor (6V@600mA)Operating Temperature / Humidity : 10˚C to 40˚C, 30-85% RH maximumStorage Temperature / Humidity : -20˚C to 60˚C, 10-95% RH maximumOperation, storage and : 700hPa to 1060hPatransport atmospheric pressureOuter Dimensions : Approx. 110 x 154 x 77mmArm Circumference : (22-32cm)Accessories : Cuff, Instruction Manual, Storage Pouch, Batteries, AC Adaptor(Optional)Classification : Application part Type BFKey to symbols : Application part Type BF : Class II equipment symbolProtection against harmful ingress of water or particulate matter : IPX0Operation mode : Continuous : Attention, Consult ACCOMPANYING DOCUMENTS.NOTE : These specifications are subject to change without notice.19
SPECIFICATIONSymbols Function / MeaningSN Serial NumberManufacturerType BF: Device, cuff and tubing are designed to provide special protection against electrical shocks.SYS Systolic Blood Pressure in mmHgDIA Diastolic Blood Pressure in mmHgPUL PulseEC Directive Medical Device LabelCautionAuthorized Representative in the European CommunityWEEE LabelRefer to instruction manual / booklet20
Appendix IThe Sphygmomanometer (MD2020/MD2030/MD2060/MD2070/MD2021/MD2031/MD2061/MD2071/MD2080) is intended for use in the electromagnetic environment specified below. The customer of the user of the Sphygmomanometer (MD2020/MD2030/MD2060/MD2070/MD2021/MD2031/MD2061/MD2071/MD2080) should assure that it is used in such an environment.The Sphygmomanometer (MD2020/MD2030/MD2060/MD2070/MD2021/MD2031/MD2061/MD2071/MD2080) uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.The Sphygmomanometer (MD2020/MD2030/MD2060/MD2070/MD2021/MD2031/MD2061/MD2071/MD2080) is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
The Sphygmomanometer (MD2020/MD2030/MD2060/MD2070/MD2021/MD2031/MD2061/MD2071/MD2080) is intended for use in the electromagnetic environment specified below. The customer of the user of Sphygmomanometer (MD2020/MD2030/MD2060/MD2070/MD2021/MD2031/MD2061/MD2071/MD2080) should assure that it is used in such an environment.
Appendix IIThe Sphygmomanometer (MD2020/MD2030/MD2060/MD2070/MD2021/MD2031/MD2061/MD2071/MD2080) is intended for use in the electromagnetic environment specified below. The customer of the user of Sphygmomanometer (MD2020/MD2030/MD2060/MD2070/MD2021/MD2031/MD2061/MD2071/MD2080) should assure that it is used in such an environment.Portable and mobile RF communications equipment should be used no closer to any part of the Sphygmomanometer (MD2020/MD2030/MD2060/MD2070/MD2021/MD2031/MD2061/MD2071/MD2080) including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
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 Sphygmomanometer (MD2020/MD2030/MD2060/MD2070/MD2021/MD2031/MD2061/MD2071/MD2080) is used exceeds the applicable RF compliance level above, the Sphygmomanometer (MD2020/MD2030/MD2060/MD2070/MD2021/MD2031/MD2061/MD2071/MD2080) should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Sphygmomanometer (MD2020/MD2030/MD2060/MD2070/MD2021/MD2031/MD2061/MD2071/MD2080) b Over the frequency range 150kHz to 80 MHz, field strengths should be less than 3 V/m.
Appendix IIIRecommended separation distances betweenportable and mobile RF communications equipment and theSphygmomanometer (MD2020/MD2030/MD2060/MD2070/MD2021/MD2031/MD2061/MD2071/MD2080)The Sphygmomanometer (MD2020/MD2030/MD2060/MD2070/MD2021/MD2031/MD2061/MD2071/MD2080) is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Sphygmomanometer (MD2020/MD2030/MD2060/MD2070/MD2021/MD2031/MD2061/MD2071/MD2080) can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Sphygmomanometer (MD2020/MD2030/MD2060/MD2070/MD2021/MD2031/MD2061/MD2071/MD2080) as recommended below, according to the maximum output power of the communications equipment.
NOTE: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:- Reorient or relocate the receiving atenna.- Increase the separation between the equipment and receiver.- Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.- Consult the dealer or an experienced technician for help.CAUTION: To comply with the limits of the Class B digital device, pursuant to Part 15 of the FCC Rules, this device is comply with Class B limits. All peripherals must be shielded and grounded. Operation with non-certified peripherals or non-shielded cables may results in interference to radio or reception.MODIFICATION: Any changes or modifications not expressly approved by the grantee of this device could void the user's authority to operate the device.Appendix IV- This device may not cause harmful interference.- This device must accept any interference received, including interference thatmay cause undesired operation.
Indication for UseDigital Automatic Blood Pressure Monitor BPM20 Series is for use by medical professional or home user. The BPM20 Series is intended to measure the systolic and diastolic blood pressure, and pulse rate of an individual (age>=16) by using a non-invasive technique, in which an inflatable cuff is wrapped around the upper arm of an individual.Appendix V
MADE IN CHINAP/N: 83-M2020-SEN00A-R #0905APEMS# E3F5-DC75Includes:• Digital Automatic Blood Pressure Monitor• Arm Cuff ( 8-1/2"-12-1/2" / 22-32cm )• Illustrated User Guide Customer Support:For questions / comments regarding the BloodPressure Monitor, you may contact manufacturer. Shanghai International Trading Corp. GmbH (Hamburg)Eiffestrasse 80, 20537 Hamburg, Germany.Grandway Technology (Shenzhen) Limited,Block 6 and 7, Zhu Keng Industrial Zone, Ping Shan, Long Gang District, Shenzhen, Guang Dong, P.R.C.Symbol for the marking of electrical and electronics devices according to Directive 2002/96/EC.The device, accessories and the packaging have to be disposed of waste correctly at the end of the usage. Please follow Local Ordinances or Regulations for disposal.0123

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