Grandway Technology MD4300 Digital Automatic Wrist Blood Pressure Monitor User Manual MD4300 manual

Grandway Technology (Shenzhen) Limited Digital Automatic Wrist Blood Pressure Monitor MD4300 manual

Users Manual

MD4300
ENGLISHPlease read these instructions for use carefully and keep them for later use, be sure to make them accessible to other users and observe the information they contain.1. Getting to know your deviceCheck that the packaging of the Sanitas MD4300 blood pres-sure monitor has not been tampered with and make sure that the required contents are present. Before use, ensure that there is no visible damage to the device or accessories and that all packaging material has been removed. If you have any doubts, do not use the device and contact your retailer or the specied Customer Services address.The wrist blood pressure monitor is used to carry out non-inva-sive measurement and monitoring of the arterial blood pressure values in adults.This allows you to quickly and easily measure your blood pres-sure, save the measured values and display the development and average values of the measured values taken.You are also warned of possible existing irregular heartbeat.The recorded values are classified and evaluated graphically.Store these instructions for use for future reference and make them accessible to other users.2. Important notes Signs and symbolsThe following symbols are used in these instructions for use, on the packaging and on the type plate for the device and the accessories:AttentionNoteNote on important informationObserve the instructions for use1. Getting to know your device ............................................... 162. Important notes ................................................................... 163. Device description .............................................................. 194. Preparing the measurement ................................................ 205. Measuring blood pressure .................................................. 226. Evaluating results ................................................................ 237. Display and delete measured values ................................. 248. Cleaning and storing the unit ............................................ 279. Error messages/troubleshooting ....................................... 2710. Technical specifications .................................................... 27Contents 11. Fcc statement .................................................... 30
Application part, type BFDirect currentDisposal in accordance with the Waste Elec -trical and Electronic Equipment EC Directive – WEEEManufacturerStor ageRH ≤93%-25°C70°CPermissible storage temperature and hu -midityOper ating5°C40°CRH 15-93 %Permissible operating temperature and humidityProtect from moistureSN Serial numberThe CE labelling certifies that the product complies with the essential requirements of Directive 93/42/EEC on medical products. Notes on use•In order to ensure comparable values, always measure your blood pressure at the same time of day.•Before every measurement, relax for about five minutes.•If you want to perform several measurements on the same person, wait ve minutes between each measurement.•Do not take a measurement within 30 minutes of eating, drinking, smoking or exercising.•Repeat the measurement if you are unsure of the measured value.•The measured values taken by you are for your information only – they are no substitute for a medical examination. Dis-cuss the measured values with your doctor and never base any medical decisions on them (e.g. medicines and their administration).•Do not use the blood pressure monitor on newborns or patients with preeclampsia. We recommend consulting a doctor before using the blood pressure monitor during preg-nancy.•In the case of restricted circulation on the arm as a result of chronic or acute vascular diseases (including vascular con-striction), the accuracy of the wrist measurement is limited. In this case you should avoid using an upper arm blood pressure monitor.•Cardiovascular diseases may lead to incorrect measure-ments or have a detrimental effect on measurement accura-cy. The same also applies to very low blood pressure, diabe-tes, circulatory disorders and arrhythmias as well as chills or shaking.•The blood pressure monitor must not be used in connection with a high-frequency surgical unit.•Only use the unit on people who have the specied wrist measurement for the device.0123Do not mofify this equipment.•
•Please note that when inating, the functions of the limb in question may be impaired.•During the blood pressure measurement, the blood circula-tion must not be stopped for an unnecessarily long time. If the device malfunctions remove the cuff from the arm.•Do not allow sustained pressure in the cuff or frequent meas-urements. The resulting restriction of the blood ow may cause injury.•Make sure that the cuff is not placed on an arm in which the ar-teries or veins are undergoing medical treatment, e.g. intravas-cular access or intravascular therapy, or an arteriovenous (AV) shunt.•Do not use the cuff on people who have undergone a mas-tectomy.•Do not place the cuff over wounds as this may cause further injury.•The blood pressure monitor can only be operated with bat-teries.•If you do not press any buttons within 30 seconds, the blood pressure monitor switches off automatically to save the bat-teries.•If you do not press any buttons within 3 minutes after a measurement, the blood pressure monitor switches off auto-matically to save the batteries.•The device is only intended for the purpose described in these instructions for use. The manufacturer is not liable for damage resulting from improper or careless use. Instructions for storage and maintenance•The blood pressure monitor is made from precision and elec-tronic components. The accuracy of the measured values and service life of the device depend on its careful handling: – Protect the device from impacts, humidity, dirt, marked temperature uctuations and direct sunlight.– Do not drop the device. – Do not use the device in the vicinity of strong electromag-netic elds and keep it away from radio systems or mobile telephones. •Do not press the buttons before the cuff is placed on the arm. Notes on handling batteries •If your skin or eyes come into contact with battery uid, rinse the affected areas with water and seek medical assistance.•Choking hazard! Small children may swallow and choke on batteries. Store the batteries out of the reach of small children.•Observe the plus (+) and minus (-) polarity signs.•If a battery has leaked, put on protective gloves and clean the battery compartment with a dry cloth.•Protect batteries from excessive heat.•Risk of explosion! Never throw batteries into a re.•Do not charge or short-circuit batteries.•If the device is not to be used for a relatively long period, take the batteries out of the battery compartment.•Use identical or equivalent battery types only. •Always replace all batteries at the same time.The PATIENT is an intended OPERATOR, and comparable healthy to normal OPERATOR.••While the EQUIPMENT is in use, no serving and maintenance can be operated.•All function and basic maintenance like change battery or clean EQUIPMENT the PATIENT can perform.
•Do not use rechargeable batteries.•Do not disassemble, open or crush the batteries. Instructions for repairs and disposal•Batteries do not belong in household waste. Please dispose of empty batteries at the collection points intended for this purpose.•Do not repair or adjust the device yourself. Proper operation can no longer be guaranteed in this case.•Repairs must only be carried out by Customer Services or au-thorised suppliers.•Do not open the device. Failure to comply will invalidate the warranty. •For environmental reasons, do not dispose of the device in the household waste at the end of its useful life. Dispose of the device at a suitable local collection or recycling point. Dispose of the device in accordance with EC Directive – WEEE (Waste Electrical and Electronic Equip-ment). If you have any questions, please contact the local authorities responsible for waste disposal.3. Device description1. Scale for classifying the measurements2. START/STOP button 3. Display4. Cuff5. Memory buttons M1 /M2M1 M23421M1 M25
Information on the display:1. Time/date2. Systolic pressure3. Diastolic pressure4. Calculated pulse value5. Irregular heartbeat symbol 6. Pulse symbol 7. User memory 8. Classication of measurements9. Number of memory space/memory display for average value ( ), morning ( ), evening ( )10. Release air (arrow)11. Battery display symbol 12. Symbol for Bluetooth® transfer System requirements for the HealthCoach appBluetooth®4.0, iOS from Version 7.0, AndroidTM devices from Version 4.3 with Bluetooth® Smart ReadyList of compatible devices: 4. Preparing the measurementInserting the batteries•Remove the battery com-partment lid on the rear of the device.• -kaline type LR03) batteries. Make sure that the batteries are inserted the correct way round. Do not use rechargeable batteries.•Close the battery compartment lid again carefully.All display elements are briey displayed, or ashes in the display. Now set the date and time as described below.If the battery replacement symbol is permanently displayed, you can no longer perform any measurements and must replace all batteries. Once the batteries have been removed from the device, the date and time must be set again. Any saved measured values are retained. The empty, completely discharged batteries must be disposed of through specially designated collection boxes, recycling points or electronics retailers. You are legally required to dispose of the batteries.The codes below are printed on batteries contain-ing harmful substances: Pb = Battery contains lead, Cd = Battery contains cadmium, Hg = Bat-tery contains mercury.123456789101112
Set the hour format, date, time and Bluetooth® settingsThe following section describes the functions and settings available on the blood pressure monitor.Hour format ➔Date ➔Time ➔Bluetooth ®It is essential to set the correct date and time. Otherwise, you will not be able to save your measured values correctly with a date and time and access them again later. If you press and hold the M1 or M2 memory button, you can set the values more quickly.Press and hold the START/STOP button for 5 seconds.All display elements are briey displayed.Hour formatThe hour format now ashes on the display.• Select the desired hour format using the M1/M2 memory buttons and conrm with the START/STOP button .DateThe year ashes on the display.• Select the year using the M1/M2 memo-ry buttons and conrm with the START/STOP button .The month ashes on the display.• Select the month using the M1/M2 mem -ory buttons and conrm with the START/STOP button .DateThe day ashes on the display.• Select the current day using the M1/M2 memory buttons and conrm with the START/STOP button . If you have set the 12h hour format, the month is displayed before the day.TimeThe hours ash on the display.• Select the current hours using the M1/M2 memory buttons and conrm with the START/STOP button .The minutes ash on the display.• Select the current minutes using the M1/M2 memory buttons and conrm with the START/STOP button .Bluetooth ®The Bluetooth ® symbol flashes on the display.• Use the M1/M2 memory buttons to select whether automatic Bluetooth ® data transfer is activated ( Blue -tooth® symbol flashes) or deactivated ( Bluetooth ® symbol is not shown) and confirm with the START/STOP button . Bluetooth ® transfers will reduce the battery life.
5. Measuring blood pressureAttach the cuff •Expose your left wrist. Ensure that the circulation of the arm is not hindered by tight clothing or similar. Place the cuff on the inside of your wrist.•Close the cuff with the hook-and-loop fastener such that the upper edge of the device is positioned approx. 1 cm under-neath the heel of the hand. •The cuff must be tted tightly around the wrist, but must not constrict. Adopt the correct posture•Before every measurement, relax for about five minutes. Otherwise deviations can occur. •You can perform the measurement while sitting or lying. To carry out a blood pressure measurement, make sure you are sitting comfortably with your arms and back leaning on something. Do not cross your legs. Place your feet flat on the ground. Make sure to rest your arm and move it. Always make sure that the cuff is at heart level. Otherwise significant deviations can occur. Relax your arm and the palm of your hand.•To avoid falsifying the measurement, it is important to remain still during the measurement and not to speak!Performing the blood pressure measurementMeasurementAs described above, attach the cuff and adopt the pos-ture in which you want to perform the measurement.•Press the START/STOP button to start the blood pressure monitor.All display elements are briefly displayed.The blood pressure monitor will begin the measurement automatically after 3 sec-onds. You can cancel the measurement at any time by pressing the START/STOP button . As soon as a pulse is found, the pulse symbol will be displayed. •The systolic pressure, diastolic pressure and pulse rate measurements are dis-played. • appears if the measurement could not be performed properly (see chapter 9 "Er-ror messages/troubleshooting"). Repeat the measurement.1 2 31 cm
Measurement•Now select the desired user memory by pressing the M1 or M2 memory buttons. If you do not select a user memory, the measurement is stored in the most re-cently used user memory. The relevant or symbol appears on the display.•Press the START/STOP button to switch off the blood pressure monitor. The measurement is then stored in the selected user memory.•If the device is not switched off manually, it will switch off automatically after 3 minutes.If Bluetooth ® data transfer has been activated, data is by transferred after having confirmed the user memory by pressing the pressing the START/STOP button . • The Bluetooth ® symbol flashes on the display. The blood pressure monitor now attempts to connect to the app for approx. 30 seconds.• The Bluetooth ® symbol stops flashing as soon as a connection is established. All measurement data is automatically transferred to the app. Once the data has been successfully transferred, the device switches off. If the data transfer was unsuccessful, “ ” appears on the display.• If a connection to the app cannot be established after 30 seconds, the Bluetooth ® symbol goes out and the blood pressure monitor switches off automatically after Measurement Please note that you must add the blood pressure monitor in "My devices" in the "HealthCoach" app to enable data transfers. The "HealthCoach" app must be active to allow data transfer. If the latest data is not displayed on your smart-phone, repeat the data transfer as described in chapter 7.If you forget to turn off the blood pressure monitor, it will switch off automatically after approximately 3 minutes. In this case too, the value is stored in the selected or most recently used user memory and the data is transferred automatically after 3 minutes if Bluetooth ® data transfer has been activated. •Wait at least 5 minutes before taking an-other measurement.6. Evaluating resultsIrregular heartbeat:This device can identify potential disruptions of the heart rhythm when measuring and if necessary, indicates this after the measurement with the symbol . This can be an indicator for irregular heartbeat. Irregular heartbeat is a condition in which the heart rhythm is abnormal because of flaws in the bioelectrical system that regulates the heartbeat. The symptoms (skipped or premature heart beats, pulse being slow or too fast) can be caused by factors such as heart disease, age, physical
make-up, excess stimulants, stress or lack of sleep. Irregular heartbeat can only be determined through an examination by your doctor. If the symbol is shown on the display after the measure-ment has been taken, repeat the measurement. Please ensure that you rest for 5 minutes beforehand and do not speak or move during the measurement. If the symbol appears frequently, please consult your doctor. Self-diagnosis and treatment based on the measurements can be dangerous. Always follow your GP’s instructions. Classication of measurements:The measurements can be classied and evaluated in accord-ance with the following table. However, these standard values serve only as a general guide-line, as the individual blood pressure varies in different people and different age groups etc. It is important to consult your doctor regularly for advice. Your doctor will tell you your individual values for normal blood pressure as well as the value above which your blood pressure is classied as dangerous.The classication on the display and the scale on the unit show which category the recorded blood pressure values fall into. If the values of systole and diastole fall into two different cate-gories (e.g. systole in the ‚High normal‘ category and diastole in the ‚Normal‘ category), the graphical classication on the de-vice always shows the higher category; for the example given this would be ‚High normal‘.Blood pressure value categorySystole (in mmHg)Diastole(in mmHg) ActionSetting 3: severe hyper -tension≥ 180 ≥ 110 seek medical attentionSetting 2: moderate hyper -tension160 – 179 100 – 109 seek medical attentionSetting 1: mild hyper -tension140 – 159 90 – 99 regular monitoring by doctor High normal 130 – 139 85 – 89 regular monitoring by doctorNormal 120 – 129 80 – 84 self-monitoringOptimal < 120 < 80 self-monitoringSource: WHO, 1999 (World Health Organization)7. Display and delete measured valuesUser memoryThe results of every successful measurement are stored together with the date and time. The oldest measurement is overwritten in the event of more than 60 measure-ments.•Select the desired user memory ( ) with the M1 or M2 memory buttons if the device is switched off.•To view the measurement data for user memory , press the M1 memory button.
User memory• To view the measurement data for user memory , press the M2 memory button. The average of all measurements appears on the display. If Bluetooth ® is activated (the symbol ashes on the display), the blood pressure monitor attempts to connect to the app. If you press the M1 button in the meantime, the transfer is cancelled and the average values for morning measurements are displayed. If you press the M2 button, the transfer is cancelled and the measurement data of user memory is displayed. The symbol is no longer shown. The buttons are deactivated as soon as a connection is established and the data is transferred. Average values Press the M1 button if you have selected user memory 1. Press the M2 memory button if you have flashes on the display. The average value of all saved measured values in this user memory is displayed. • Press the relevant memory button ( M1 or M2 ).Average values ashes on the display. The average value of the morning measure-ments for the last 7 days is displayed (morn-ing: 5.00 a.m. – 9.00 a.m.).Press the relevant memory button (M1 or M2 ). ashes on the display. The average value of the evening meas-urements for the last 7 days is displayed (evening: 6.00 p.m. – 8.00 p.m.).Individual measured valuesWhen the relevant memory button (M1 or M2 ) is pressed again, the last individual measurement is displayed (in this example, measurement 03).When the relevant memory button (M1 or M2 ) is pressed again, you can view your individual measurements.• To switch the device off again, press the START/STOP button . If you forget to turn off the blood pressure monitor, it You can exit the menu at any time by pressing the START/STOP button .
Delete the measured values• To clear the memory of the relevant user memory, you must first select a user memory. • Start the retrieval of the average measured values. A ashes on the display and the average value of all saved measured values in this user memory is dis-played.• Press and hold the memory button M1 or M2 for 5 seconds depending on the user memory you are in.All the values in the current user memory are deleted.If Bluetooth ® is activated (the symbol ash-es on the display), the blood pressure monitor attempts to connect to the app. When the symbol is ashing, it is not possible to de-lete all values from the selected user memory.Deleting individual measurementsTo clear individual measurements from the relevant user memory, you must first select a user memory.• Start the retrieval of the individual measured values.• Press and hold the memory button M1 or M2 for 5 seconds (depending on the user memory you are in).• The selected value is deleted. The device briey dis-plays CL 00.• If you would like to delete other values, repeat the pro-cess described above.You can switch off the device at any time by pressing the START/STOP button.Transfer via Bluetooth ® SmartIt is also possible to transfer the measured values saved on the device to your smartphone using Bluetooth ® Smart. You will need the HealthCoach app for this. The app is availa-ble from the App Store.Proceed as follows to transfer values: If Bluetooth ® is activated in the settings menu, the data is transferred automatically after the measurement. The symbol appears in the top left of the display (see chapter 4 „Preparing the measurement“).Step 1: MD4300Activate Bluetooth ® on your device (see chapter 4 "Preparing the measurement“, Blue -tooth®). Step 2: "HealthCoach" appIn the HealthCoach app, add the MD4300 under "Settings/My devices". Step 3: MD4300take a measurement.
Step 4: MD4300data transfer immediately following measurements.•If Bluetooth ® data trans -fer has been activated, data is by transferred after having confirmed the user memory by pressing the pressing the START/STOPbutton .Step 4: MD4300Data transfer at a later point:•Go to memory mode (chapter 7). Select the desired user memory. The Bluetooth ® transfer starts automatically. The HealthCoach app must be active to allow data transfer.If your smartphone has a protective cover, remove this to en -sure that there is no interference during the transfer. Begin the data transfer in the HealthCoach app.8. Cleaning and storing the unit•Clean the device and cuff carefully using a slightly damp cloth only.•Do not use any cleaning agents or solvents.•Under no circumstances should you hold the unit under wa-ter, as this can cause liquid to enter and damage the unit.•If you store the device, no heavy objects should be placed on top of it. The cuff line should not be bent sharply.In such cases, repeat the measurement and/or data transfer. Ensure that the cuff line is correctly attached and that you do not move or speak during the measurement.9. Error messages/troubleshootingIn the event of errors, the error message _ appears on the display.Error messages may appear if:• it was not possible to record the pulse: ;• you move or speak during the measurement: ;• the cuff is fastened too tightly or loosely: ;• errors occur during the measurement: ;• the pump pressure is higher than 300 mmHg: ;• the batteries are almost empty : ;• the data could not be sent via Bluetooth ®.The word mark Bluetooth ® and accompanying logo are reg -istered trademarks of Bluetooth ®SIG, Inc. Any and all use of these marks by Hans Dinslage GmbH is done so under licence. Other trademarks and trade names are the property of the relevant holder.10. Technical specificationsModel No. MD4300Measurement methodOscillometric, non-invasive blood pres -sure measurement on the upper armMeasurement rangePulse 40 – 180 beats/minuteDisplay accuracy Systolic ± 3 mmHg, Diastolic ± 3 mmHg, Pulse ± 5 % of the value shown
28Measurement inac -curacyMax. permissible standard deviation according to clinical testing: Systolic 8 mmHg / Diastolic 8 mmHgMemory 2 x 60 memory spacesDimensions L 78 mm x W 63 mm x H 23 mmWeight 66.5 g (Without cuff and batteries)Cuff size 14 to 19.5 cmPermissible operating conditions+ 5°C to + 40°C, 15-93% relative humid -ity (non-condensing)Permissible storage conditions-25°C to + 70°C, ≤ 93% relative humidity, 700 –1060 hPa ambient pressurePower supply AAA batteries Battery life Lasts for approx. 200 measurements depending on the blood pressure and pump pressure as well as the number of Bluetooth ® connections.Accessories Instructions for use, storage boxClassification Internal supply, IP22, no AP or APG, continuous operation, application part type BFData transfer via Bluetooth ® wireless technologyThe blood pressure monitor uses Bluetooth ®frequency band, compatible with Blue -tooth 4.0 smartphones/tabletsList of supported smartphones/tabletsTechnical information is subject to change without notification to allow for updates.•This device complies with European Standard EN60601-1-2 and is subject to particular precautions with regard to electromagnetic compatibility. Please note that portable and mobile HF communication systems may interfere with this unit. More details can be requested from the stated Custom-er Services address or found at the end of the instructions for use.•The device complies with the EU Medical Devices Directive 93/42/EEC, the German Medical Devices Act (Medizinpro-duktgesetz) and the standards EN1060-1 (non-invasive EN1060-3 (non-invasive sphygmomanometers – Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems) and IEC80601-2-30 (Medical electrical equipment – Part 2 – 30: Particular requirements
29for the basic safety and essential performance of automated non-invasive sphygmomanometers).•The accuracy of this blood pressure monitor has been carefully checked and developed with regard to a long useful life. If using the device for commercial medical purposes, it must be regularly tested for accuracy by appropriate means. Precise instructions for checking accuracy may be requested from the service address.•We hereby guarantee that this product complies with the European R&TTE Directive 1999/5/EC.Please contact the specified service address to obtain more detailed information such as the CE conformity declaration.
Changes or modifications to the product not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.NOTE: This equipment has been tested and found to comply with the limits for a Class B digital device, pur-suant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equiprement gernerates, 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 inter-ferenceto 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 followingmeasures:– Reorient or elocate the receiving antenna.– Increase the separation between the equipment and receiver.– Connect the equipment into an outlet on a circuit different fromthat to which the receiver is connected.– Consult the dealer or an experienced radio/TV technician for help.11. FCC statementSubject to errors and changes30This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:(1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.
Symbol for the marking of electrical and electronics devices according toDirective 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 orRegulations for disposal.MADE IN CHINAP/N: 83-M4300-SEN00A-R #1201A 0123Shanghai International Trading Corp. GmbH (Hamburg)Eiffestrasse 80, 20537 Hamburg, Germany.Grandway Technology (Shenzhen) Limited,Block 7, Zhu Keng Industrial Zone, Ping Shan District, 518118 Shenzhen, PEOPLE’S REPUBLIC OF CHINAPEMS# E3F5-DC75

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