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Summary of Contents for MX HEALTH MX86005
- Page 1 COMPACT BLOOD PRESSURE ™ MONITOR USER MANUAL MODEL: MX86005 Arrythmia TABLE OF CONTENTS Multi-users BP Indicator Detection (IHB) 120 Memories...
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Page 2: Table Of Contents
TABLE OF CONTENTS IMPORTANT INFORMATION ......3 CONTENTS AND DISPLAY INDICATORS ....4 INTENDED USE . -
Page 3: Important Information
IMPORTANT INFORMATION NORMAL BLOOD PRESSURE FLUCTUATION All physical activity, excitement, stress, eating, drinking, smoking, body posture and many other activities or factors (including taking a blood pressure measurement) will influence blood pressure value. Because of this, it is mostly unusual to obtain identical multiple blood pressure readings. Blood pressure fluctuates continually, day and night. The highest value usually appears in the daytime and lowest one usually at midnight. Typically, the value begins to increase at around 3:00AM, and reaches to highest level in the daytime while most people are awake and active. Considering the above information, it is recommended that you measure your blood pressure at approximately the same time each day. Measuring too frequently may cause injury due to blood flow interference. Please always relax for a minimum of 1 to 1.5 minutes between measurements to allow the blood circulation in your arm to recover. It is rare that you obtain identical blood pressure readings each time. -
Page 4: Contents And Display Indicators
CONTENTS AND DISPLAY INDICATORS Heart beat symbol Zero-seeking Low Battery Irregular Heart beat symbol INTENDED USE This fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home 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 upper arm. -
Page 5: Contraindication
CONTRAINDICATION It is inappropriate for people with serious arrhythmia to use this Electronic Sphygmomanometer. PRODUCT DESCRIPTION Based on Oscillometric methodology and silicon integrated pressure sensor, blood pressure and pulse rate can be measured automatically and non-invasively. The screen will show blood pressure and pulse rate. The most recent 4×30 measurements can be stored in the memory with date and time stamp.The Electronic Sphygmomanometers corresponds to the below standards: IEC 60601-1:2005 +A1:2012(E)/EN 60601- 1:2006/A11: 2011 (Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance), IEC60601- 1-2:2014/EN 60601-1-2:2015 /AC:2010 (Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests), IEC80601-2-30:2009+AMD1:2013/ EN 80601-2-30:2010/A1:2015(Medical electrical equipment –Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers)EN 1060-1: 1995 + A2: 2009 (Non-invasive sphygmomanometers - Part 1: General requirements), EN 1060-3: 1997 + A2: 2009 (Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems). ISO81060-2 2013(Non-Invasive Sphygmomanometers - Part 2: Clinical Validation OfAutomated Measurement Type). -
Page 6: Specifications
SPECIFICATIONS 1. Product name: mx™ Compact Blood Pressure Monitor 2. Model: MX86005 3. Classification: Internally powered, Type BF applied part,IP22,No AP or APG,Continuous operation 4. Machine size: Approx. 150mm×95mm×41mm 5. Cuff circumference: 22cm - 42cm 6. Weight: Approx. 166g (5 27/32oz.) (exclude batteries) 7. Measuring method: Oscillometric method, automatic inflation and measurement 8. Memory volume: 4×30 times with time and date stamp 9. Power source: batteries: 4 ×1.5V SIZE AAA 10. Measurement range: Cuff pressure: 0-300mmHg Systolic: ..60-260mmHg Diastolic: .. 40-199mmHg Pulse rate: 40-180 beats/minute 11. Accuracy: Pressure: .. ±3mmHg Pulse rate: Less than 60: ±3bpm More than 60 (incl.) : ±5% Precision of the displayed values: 1mmHg 12. Environmental temperature for operation: 10°C - 40°C (50°F - 104°F) 13. Environmental humidity for operation: ≤85%RH... -
Page 7: Notice
NOTICE 1. Read all of the information in the operation guide and any other literature in the box before operating the unit. 2. Stay still, calm and rest for 5 minutes before blood pressure measurement. 3. The cuff should be placed at the same level as your heart. 4. During measurement, neither speak nor move your body and arm. 5. Measure on the same arm for each measurement. 6. Please always relax at least 1 or 1.5 minutes between measurements to allow the blood circulation in your arm to recover. Prolonged over-inflation (cuff pressure exceed 300 mmHg or maintained above15 mmHg for longer than 3 minutes) of the bladder may cause ecchymoma of your arm. 7. Consult your physician if you have any doubt about below cases: 1) The application of the cuff over a wound or inflammation diseases; 2) The application of the cuff on any limb where intravascular access or therapy, or an arterio-venous (A-V) shunt, is present; 3) The application of the cuff on the arm on the side of a mastectomy; 4) Simultaneously used with other monitoring medical equipments on the same limb; 5) Need to check the blood circulation of the user. 8. This Electronic Sphygmomanometers is designed for adults and should never be used on infants or young children. Consult your physician or other health care professionals before use on older children. 9. Do not use this unit in a moving vehicle, this may result in erroneous measurements. - Page 8 sphygmomanometers. 11. Information regarding potential electromagnetic or other interference between the blood pressure monitor and other devices together with advice regarding avoidance of such interference please see part ELECTROMAGNETIC COMPATIBILITY INFORMATION. 12. If Irregular Heartbeat (IHB) brought on by common arrhythmias is detected in the procedure of blood pressure measurement, a signal will be displayed. Under this condition, the Electronic Sphygmomanometer can keep function, but the results may not be accurate, it’s suggested that you consult with your physician for accurate assessment. There are 2 conditions under which the signal of IHB will be displayed: 1) The coefficient of variation (CV) of pulse period >25%. 2) The difference of adjacent pulse period ≥0.14s, and the number of such pulse takes more than 53 percentage of the total number of pulse. 13. Please do not use a cuff other than supplied by the manufacturer, otherwise it may bring biocompatible hazard and might result in measurement errors. 14. The monitor might not meet its performance specifications or cause safety hazard if stored or used outside the specified temperature and humidity ranges in specifications. 15. Please do not share the cuff with an infective person to avoid cross-infection. 16. 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...
- Page 9 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 antenna. — 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 radio/TV technician for help. 17. Measurements are not possible in patients with a high frequency of arrhythmias. 18. The device is not intended for use on neonates, children or pregnant women. (Clinical testing has not been conducted on neonates, children or pregnant women.) 19. Motion, trembling or shivering may affect the measurement reading. 20. The device would not apply to the patients with poor peripheral circulation, noticeably low blood pressure, or low body temperature (there will be low blood flow to the measurement position). 21. The device would not apply to the patients who use an artificial heart and lung (there will be no pulse) 22. Consult your physician before using the device for any of the following conditions: common arrhythmias such as atrial or ventricular premature beats or atrial fibrillation, arterial sclerosis, poor perfusion, diabetes, pre-eclampsia, renal diseases. 23. The patient can be an intended operator. 24. Attention that changes or modification not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment. 25. Swallowing batteries and/or battery fluid can be extremely dangerous. Keep the batteries and the unit out of the reach of children and disabled persons.
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Page 10: Setup And Operating Procedures
SETUP AND OPERATING PROCEDURES BATTERY LOADING a. Open battery cover at the back of the monitor. b. Load four “AAA” size batteries. Please pay attention to polarity. c. Close the battery cover. • When the screen shows the battery symbol replace all batteries with new ones. • Rechargeable batteries are not suitable for this monitor. • Remove the batteries if the monitor will not be used for a month or more to avoid relevant damage of battery leakage. • Avoid the battery fluid getting into your eyes. If it should get in your eyes, immediately rinse with plenty of clean water and contact a physician. The negative terminal of the battery needs to be compressed into the battery compartment properly after horizontal compression of the negative electrode. The battery is in contact with the spring Make sure the battery cover is intact and not damaged before installing the battery The monitor, the batteries and the cuff, must be disposed of according to local regulations at the end of their usage. - Page 11 d. You can turn off the monitor by pressing “START” button when the minute is blinking, then the time and date is stored. e. The monitor will turn off automatically after 30 seconds of no operation with the time and date unchanged. f. Once you change the batteries, you should readjust the time and date. Note: 2.1 The clock format could be set by user. 2.2 Table 1 instructs the conversion relations between 24 hour format and 12 hour format...
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Page 12: Connecting The Cuff To The Monitor
3. CONNECTING THE CUFF TO THE MONITOR Insert the cuff tubing connector into the socket on the left side of the monitor. Ensure that the connector is completely inserted to avoid air leakage during blood pressure measurements. Avoid compression or restriction of the connection tubing during measurement, which may cause inflation error, or harmful injury due to continuous cuff pressure. 4. APPLYING THE CUFF a. Pulling the cuff end through the metal loop (the cuff is packaged like this already), turn it outward (away from your body) and tighten it and close the Velcro fastener. b. Place the cuff around a bare arm 1-2cm above the elbow joint. c. While seated, place palm upside in front of you on a flat surface such as a desk or table. Position the air tube in the middle of your arm in line with your middle finger. d. The cuff should fit comfortably, yet snugly around your arm. You should be able to insert one finger between your arm and the cuff. Note: • Please refer to the cuff circumference range in “SPECIFICATIONS” to make sure that the appropriate cuff is used. • Measure on the same arm each time. -
Page 13: Body Posture During Measurement
• Do not move your arm, body, or the monitor and do not move the rubber tube during measurement. • Stay quiet, calm for 5 minutes before blood pressure measurement. • Please keep the cuff clean. If the cuff becomes dirty, remove it from the monitor and clean it by hand in a mild detergent, then rinse it thoroughly in cold water. Never dry the cuff in clothes dryer or iron it. 5. BODY POSTURE DURING MEASUREMENT Sitting Comfortably Measurement a. Be seated with your feet flat on the floor, and don’t cross your legs. b. Place palm upside in front of you on a flat surface such as a desk or table. c. The middle of the cuff should be at the level of the right atrium of the heart. Lying Down Measurement a. Lie on your back. b. Place your left arm straight along your side with your palm facing up. c. The cuff should be placed at the same level as your heart. 6. TAKING YOUR BLOOD PRESSURE READING a. With the batteries inserted correctly, the cuff around the arm, the body in a comfortable position, and the display on the screen normal, the device is ready for use. Press the “START” button. A beep is heard and all display characters are shown for self-test. -
Page 14: Displaying Stored Results
b. Then the current memory bank ( or ) is shown. Press “MEM” button to change over to other bank. Confirm your selection by pressing “START” button. The current bank can also be confirmed automatically after 5 seconds with no operation. c. Then the monitor inflates the cuff until sufficient pressure has built up for a measurement. Then the monitor slowly releases air from the cuff and carries out the measurement. Finally the blood pressure and pulse rate will be calculated and displayed on the LCD screen. The blood pressure classification indicator and irregular heartbeat symbol (if any) will blink on the screen. The result will be automatically stored in the monitor. d. After measurement, the monitor will turn off automatically after 1 minute of no operation. e. During measurement, you can press the “START/STOP”button to turn off the monitor manually. Note: Please consult a health care professional for interpretation of pressure measurements. 7. DISPLAYING STORED RESULTS a. In StandBy Mode, press “MEM” button, the monitor will display sign of current group. The amount of results in current user memory zone will be displayed. (See picture 7). Press “START/STOP” button to switch group, press “MEM” to confirm current group. Then screen will display the average of all results in the current user memory zone. (See picture 7-1). If no result stored in the current user memory zone, screen will display “0” for blood pressure and pulse rate (See picture 7-2). - Page 15 b. Press “MEM” button, the screen will display the average value of all the results which is measured from 5 o’clock to 9 o’clock in last 7 days in the current user memory zone. (See picture 7-3). If no result stored from 5 o’clock to 9 o’clock in last 7 days, the screen will display “0” for blood pressure and pulse rate. (See picture 7-4) c. Press “MEM” button again, the screen will display the average value of all the results which is measured from 8h00 to 20h00 in last 7 days in the current user memory zone. (See picture 7-5) If no result stored from 18h00 or 6 o’clock PM system in last 7 days, the screen will display “0” for blood pressure and pulse rate. (See picture 7-6). d. Then press the “MEM” button and the most recent result will be displayed. (See picture 7-7). Irregular heartbeat symbol (if any) and blood pressure classification indicator will blink the same time. If the monitor has no result stored in the current user memory zone, the screen will display “0” for blood pressure and pulse rate. (See picture 7-8). e. Press “MEM” button again to review the next result. (See picture 7-9). In this way, repeatedly pressing the “MEM” button displays the respective results measured previously. f. When reviewing the results, the monitor will turn off automatically after 1 minute of no operation. You can also press the “START/STOP” button to turn off the monitor manually. Note: When the monitor displaying the measurement, the classification color indicator can be shown different color according to the systolic pressure and diastolic pressure.
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Page 16: Deleting Measurements From The Memory
8. DELETING MEASUREMENTS FROM THE MEMORY When any result is displayed, hold the “MEM” button for three seconds, and all results will be deleted. Press the “MEM” or “START” button and the monitor will turn off. 9. ASSESSING HIGH BLOOD PRESSURE FOR ADULTS The following guidelines for assessing high blood pressure (without regard to age or gender) have been established by the World Health Organization (WHO). Please note that other factors (e.g. diabetes, obesity, smoking, etc.) need to be taken into consideration. Consult with your physician for accurate assessment, and never change your treatment by yourself. Should the Blood Pressure Readings be of such a nature that it is of concern, consult a healthcare professional for advice. -
Page 17: Technical Alarm Description
Note: It is not intended to provide a basis of any type of rush toward emergency conditions/diagnosis based on the color scheme and that the color scheme is meant only to discriminate between the different levels of blood pressure. 10. TECHNICAL ALARM DESCRIPTION The monitor will show 'HI' or 'Lo' as technical alarm on the screen with no delay if the determined blood pressure (systolic or diastolic) is outside the rated range specified in SPECIFICATIONS. In this case, you should consult a physician or check if your operation violated the instructions. The technical alarm condition (outside the rated range) is preset in the factory and cannot be adjusted or deactivated. This alarm condition is assigned as low priority according to IEC 60601-1-8. The technical alarm is non-latching and does not need to be reset. The signal displayed on the screen will disappear automatically after about 8 seconds. -
Page 18: Troubleshooting
TROUBLESHOOTING PROBLEM POSSIBLE CAUSE SOLUTION The cuff position was not Apply the cuff correctly and correct or it was not properly try again. tightened Review the “BODY POSTURE Body posture was not correct DURING MEASUREMENT” during testing sections of the instructions and re-test. The screen shows abnormal result Speaking, arm or body Re-test when calm and without movement, angry, excited or speaking or moving during nervous during testing the test. It is inappropriate for people Irregular heartbeat with serious arrhythmia to use (arrhythmia) this Electronic Sphygmoma- nometer. Low battery symbol Low Battery Change the batteries Pressure system is unstable The screen shows Er 0 before measurement Don’t move and try again. The screen shows Er 1 Fail to detect systolic pressure Fail to detect diastolic The screen shows Er 2 pressure Pneumatic system blocked The screen shows Er 3... -
Page 19: Maintenance
PROBLEM POSSIBLE CAUSE SOLUTION No response when you Remove the batteries for five Incorrect operation or strong press button or load minutes, and then reinstall all electromagnetic interference. battery. batteries. MAINTENANCE 1. Do not drop this monitor or subject it to strong impact. 2. Avoid high temperature and solarisation. Do not immerse the monitor in water as this will result in damage to the monitor. 3. If this monitor is stored in cold temperatures, allow it to acclimatise to room temperature before use. 4. Do not attempt to disassemble this monitor. 5. If you do not use the monitor for a long time, please remove the batteries. 6. It is recommended the performance should be checked every 2 years or after repair. Please contact the service center. 7. Clean the monitor with a dry, soft cloth or a soft cloth squeezed well after moistened with water, diluted disinfectant alcohol, or diluted detergent. 8. No component inside this monitor is serviceable by the user. The circuit diagram, component part list, calibration instructions and other information which can assist an appropriately qualified technician to repair this device, can be supplied. 9. The monitor can maintain the safety and performance characteristics for a minimum of 10,000 measurements or three years, and the cuff integrity is maintained after 1,000 open–close cycles of the closure.. -
Page 20: Explanation Of Symbols On Unit
11. T he monitor requires 6 hours to warm from the minimum storage temperature between uses until the monitor is ready for its INTENDED USE when the ambient temperature is 20 °C. 12. T he monitor requires 6 hours to cool from the maximum storage temperature between uses until the monitor is ready for its INTENDED USE when the ambient temperature is 20 °C. 13. N o servicing/maintenance while the monitor is in use. CLASSIFICATION AND EXPLANATION OF SYMBOLS Symbols Meaning Warning / Caution / Note Type BF equipment Consult instructions for use Manufacturer Date of manufacture Serial number Disposal of Electrical & Electronic Equipment (WEEE): Do not treat this product as a household waste. Symbol for “KEEP DRY” 50°C Storage temperature Min -20°C Max 50° C -20°C Compiles with MDD93/42/EEC Requirements 0197 European representation IP20 The first characteristic numeral symbol for “Degrees of protection against access to hazardous parts and against solid foreign objects “.The second characteristic numeral symbol for “Degrees of protection against ingress of water” CUSTOMER CARE Should you experience any adverse effect from the use of this device, discontinue use and report to us at customercare@medinox.co.uk. -
Page 21: Electromagnetic Compatibility Information
ELECTROMAGNETIC COMPATIBILITY INFORMATION TABLE 1 - EMISSION Phenomenon Compliance Electromagnetic environment CISPR 11 RF emissions Home healthcare environment Group 1, Class B IEC 61000-3-2 Harmonic distortion Home healthcare environment Class A Voltage fluctuations IEC 61000-3-3 Home healthcare environment and flicker Compliance TABLE 2 - ENCLOSURE PORT Immunity test levels Basic EMC Phenomenon Home Healthcare standard Environment ±8 kV contact Electrostatic Discharge IEC 61000-4-2 ±2kV, ±4kV, ±8kV, ±15kV air 10V/m Radiated RF EM field IEC 61000-4-3 80MHz-2.7GHz 80% AM at 1kHz Proximity fields from RF wireless communications IEC 61000-4-3 Refer to table 3 equipment Rated power frequency 30A/m... - Page 22 TABLE 3 – PROXIMITY FIELDS FROM RF WIRELESS COMMUNICATIONS EQUIPMENT Immunity test levels Test frequency Band (MHz) Professional healthcare facility (MHz) environment 380-390 Pulse modulation 18Hz, 27V/m 430-470 FM, ±5kHz deviation, 1kHz sine, 28V/m 704-787 Pulse modulation 217Hz, 9V/m 800-960 Pulse modulation 18Hz, 28V/m 1720 1845 1700-1990 Pulse modulation 217Hz, 28V/m 1970 2450 2400-2570 Pulse modulation 217Hz, 28V/m 5240 5500 5100-5800 Pulse modulation 217Hz, 9V/m 5785...
- Page 24 Exclusively manufactured for and distributed by: Medinox London Limited. Solar House,282 Chase Road, London N14 6NZ . www.medinox.co.uk MX Health ™ is an exclusive trademark of Medinox London. Andon Health Co.,Ltd, No 3 Jinping Street, YaAn Road, Nankai District, Tianjin, 300190, China iHealth Labs Europe SAS, 36 rue de Ponthieu, 75008, Paris, France.
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