PROFICARE PC-BMG 3019 Blood Pressure Monitoring Device Instruction Manual

PROFICARE PC-BMG 3019 Blood Pressure Monitoring Device

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 identi-cal multiple blood pressure readings. Blood pressure fluctuates continually — day and night. The highest value usually appears in the daytime and the lowest one usually at midnight. Typically, the value begins to increase at around 3:00 AM, 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. Too frequent measurements may cause injury due to blood flow interference, please always relax 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.

Contents and Display Indicators

1. LCD display
2. Button MEM
3. Button START
4. Cuff
5. Cuff tubing connector socket
6. Low battery indicator
7. Systolic pressure
8. Diastolic pressure / pulse rate display (alternating)
9. Date / Time display (alternating)
10. Memory indicator
11. Irregular heartbeat symbol
12. Blood pressure level classification Indicator
13. “Ready to inflate” indicator10 Memory indicator
14. Irregular heartbeat symbol
15. Blood pressure level classification Indicator
16. “Ready to inflate” indicator

Intended Use

The fully automatic electronic sphygmomanometer is for use by medical profession-als or at home. It is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individ-ual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 30 cm – 42 cm.

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 LCD display will show blood pressure and pulse rate. The most recent 2 × 60 measure-ments can be stored in the memory with date and time stamp. The monitor can also show the average reading of the last three measurements.
The electronic sphygmomanometers corresponds to the below standards: IEC 60601-1 Edition 3.1 2012-08 / EN 60601-1: 2006 / A1: 2013 (Medical electrical equipment – Part 1: General requirements for basic safety and essential perfor-mance), IEC60601-1-2: 2014 / EN 60601-1-2: 2015 (Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collat-eral standard: Electromagnetic compatibility – Requirements and tests), IEC 80601-2-30: 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 sphygmomanometer), EN 1060-1: 1995 + A2: 2009 (Non-invasive sphygmomanometers – Part 1: General requirements), EN 1060-3: 1997 + A2: 2009 (Non-invasive sphygmomanom-eters – Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems), ISO 81060-2: 2013 (Non- invasive sphygmomanometers – Part 2: Clinical validation of automated measurement type).

Specifications

1. Product name: Blood pressure monitor
2. Model: PC-BMG 3019 (KD-558BR)
3. Classification: Internally powered, Type BF applied part, IP20 (Level of protection against touching and foreign objects), No AP or APG, Continuous operation
4. Appliance size: Approx. 138 mm × 98 mm × 48 mm
5. Cuff circumference: 30 cm – 42 cm
6. Weight: Approx. 300 g (batteries and cuff excluded)
7. Measuring method: Oscillometric method, automatic inflation and measurement
8. Memory volume: 2 × 60 measurements with time and date stamp
9. Power source: Batteries: 4 × 1.5 V type AA Mignon LR6
10. Measurement range:
11. Cuff pressure: 0 – 300 mmHg
12. Systolic: 60 – 260 mmHg
13. Diastolic: 40 – 199 mmHg
14. Pulse rate: 40 – 180 beats / minute
15. Accuracy
16. Pressure: ± 3 mmHg
17. Pulse rate: ± 5 %
18. Environmental temperature for operation: +10 °C to +40 °C (50 °F to 104 °F)
19. Environmental humidity for operation: ≤ 85 % RH
20. Environmental temperature for storage and transport: -20 °C to +50 °C (-4 ° to 122 °F)
21. Environmental humidity for storage and transport: ≤ 85 % RH
22. Environmental pressure: 80 kPa to 105 kPa
23. Battery life: Approx. 270 measurements
24. Scope of Delivery: Pump, valve, LCD, cuff, sensor
25. Package contents: 1 blood pressure monitor with attached wrist cuff; 1 operation guide; 1 plastic bag

Notices

1. Read all of the information in the operation guide and any other literature in the box before operating the appliance.
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. Measuring on same arm each time.
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 above 15 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:
8. The application of the cuff over a wound or inflammation diseases;
9. The application of the cuff on any limb where intravascular access or therapy, or an arterio-venous (A-V) shunt, is present;
10. The application of the cuff on the arm on the side of a mastectomy or lymph node clearance;
11. Simultaneously used with other monitoring medical equipments on the same limb;
12. Need to check the blood circulation of the user
13. This electronic sphygmomanometer is designed for adults and should never be used for infants or young children. Consult your physician or other health care professionals before use on older children. Pregnant women including pre-eclampsia patients should always ask their physician whether they can use this blood pressure monitor.
14. Do not use this appliance in a moving vehicle, This may result in erroneous measurement.
15. Blood pressure measurements determined by this monitor are equivalent to those obtained by a trained observer using the cuff/stethoscope auscultation method, within the limits prescribed by the American National Standard Institute, Electronic or automated sphygmomanometers.
16. Use of the appliance adjacent to or stacked with other equipment should be avoided because it could result in improper operation. Information regarding potential electromagnetic or other interference between the blood pressure monitor and other appliances together with advice regarding avoidance of such interference please see part “Electromagnetic Compatibility Information”. It is suggested that the blood pressure monitor be kept 30 centimeters away from other wireless appliances, such as WLAN unit, microwave oven, etc. It can’t be used near active HF SURGICAL EQUIPMENT and the RF shielded room of an ME SYSTEM for magnetic resonance imaging, where the intensity of EM DISTURBANCES is high.
17. If an irregular heartbeat (IHB) from common arrhythmias is detected in the procedure of blood pressure measurement, this sign will be displayed. Under this condition, the electronic sphygmomanometers can keep function, but the results may not be accurate, it’s suggested that you consult with your physician for accurate assessment.
18. The coefficient of variation (CV) of the pulses is > 25 %.
19. The deviation of the following pulse period is ≥ 0.14 s, and the number of such pulses amounts to more than 53 % of the total number of measured pulses.
20. Please do not use the cuff other than supplied by the manufacturer, otherwise it may bring biocompatible hazard and might result in measurement error.
21. The monitor might not meet its performance specifications or cause a safety hazard if stored or used outside the temperature and humidity ranges specified in the specifications.
22. Please do not share the cuff with other contagious persons to avoid cross-infection.
23. This equipment has been tested and found to comply with the limits for a Class B digital appliance, 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 guaranteethat 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:
24. Reorient or relocate the receiving antenna.
25. Increase the distance between the equipment and the receiver.
26. Connect the appliance to an outlet on a circuit different from that to which the receiver is connected.
27. Consult the dealer or an experienced radio / TV technician for help
28. Measurements are not possible in patients with a high frequency of arrhythmias.
29. The appliance is not intended for use on neonates, children or pregnant women. (Clinical testing has not been conducted on neonates, children or pregnant women.)
30. Motion, trembling, shivering may affect the measurement reading.
31. The appliance would not apply to patients with poor peripheral circulation, noticeably low blood pressure, or low body temperature (there will be low blood flow to the measurement position).
32. The appliance would not apply to the patients who use an artificial heart and lung (there will be no pulse).
33. Consult your physician before using the appliance 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.
34. If you are allergic to plastic / rubber, please don’t use this appliance.
35. The patient can be an intended operator.
36. Swallowing batteries and / or battery fluid can be extremely dangerous. Keep the batteries and the appliance out of the reach of children and disabled persons

Setup and Operating Procedures

Battery Loading

1. Open battery cover at the back of the monitor.
2. Load four batteries of the type “AA”. Please pay attention to polarity.
3. Close the battery cover

When the LCD 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. Do not let battery fluid get into your eyes. If it should get in your eyes, immediately rinse with plenty of clean water and contact a physician  The monitor, the batteries and the cuff, must be disposed of according to local regulations at the end of their usage

Clock and Date Adjustment

1. Once you install the battery or turn off the monitor, it will enter Clock Mode, and LCD will display time and date by turns. See Fig. 2-1 & 2-2.
2. While the monitor is in Clock Mode, pressing the “START” button and the “MEM” button simultaneously; a beep is heard and the month will flash first. See Fig. 2-3. Press the button “START” repeatedly; the day, the hour and the minute will flash in turn. While a number is flashing, press the button “MEM” to increase the number. Keep on pressing the button “MEM”, the number will increase fast.
3. You can turn off the monitor by pressing the “START” button when the minutes are flashing, then the time and the date are confirmed.
4. The monitor will turn off automatically after 1 minute of no operation; with the time and date unchanged.
5. After replacing the batteries, you should set the time and the date again.

Connecting the Cuff to the Monitor
Insert the cuff tubing connector into the socket in the left side of the monitor. Make certain that the connector is completely inserted to avoid air leakage during blood pressure measurements.  Avoid compression or restriction of the connection tubing during measurement, as this may cause an inflation error or harmful injury due to continuous cuff pressure

Applying the Cuff

1. If required, pull the cuff end through the medal loop (the cuff is packaged like this already).
2. Place the cuff around a bare arm 1 to 2 cm above the elbow joint.
3. While sitting, place your hand with the palm facing up onto a flat surface like a table or similar. Position the air tube in the middle of your arm in line with your middle finger.
4. Tighten the cuff and close the Velcro fastener. 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:

1. Please refer to the cuff circumference range in “Specifications” to make sure that the appropriate cuff is used.
2. Measuring on same arm each time.
3. Do not move your arm, body, or the monitor and do not move the rubber tube during measurement.
4. Stay quiet, calm for 5 minutes before blood pressure measurement.
5. Please keep the cuff clean. If the cuff becomes dirty, remove it from the monitor and clear it by hand in a mild detergent, then rinse it thoroughly in cold water. Never dry the cuff in clothes dryer or iron it. Clean the cuff after the usage of every 200 times is recommended

Body Posture during Measurement

Sitting Comfortably Measurement

1. Be seated with your feet flat on the floor, and don’t cross your legs. Support the back with the backrest of the chair.
2. Place palm upside in front of you on a flat surface such as table.
3. The middle of the cuff should be at the level of the right atrium of the heart.

Lying Down Measurement

1. Lie on your back.
2. Place your arm straight along your side with your palm upside.
3. The cuff should be placed at the same level as your heart.

Taking Your Blood Pressure Reading

1. After applying the cuff and with your body in a comfortable position, press the “START” button. A beep is heard and all display characters are shown for selftest. See Fig. 6-1. Please contact the service centre if a segment is missing.
2. Then the current memory bank (U1 or U2) is flashing. See Fig. 6-2. Press the “MEM” button to change to the other bank. See Fig. 6-3. Confirm your selection by pressing the “START” button. The current bank will also be confirmed automatically after 5 seconds with no operation.
3. After selecting the memory bank, the monitor starts to seek zero pressure. See Fig. 6-4.
4. 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 separately. Irregular heartbeat symbol (if any) will blink. See Fig. 6-5 & 6-6. The result will be automatically stored in the current memory bank.
5. After measurement, the monitor will turn off automatically after 1 minute of no operation. You can also press the “START” button to turn off the monitor manually.
6. During measurement, you can press the “START” button to turn off the monitor manually.

Note:
Please consult a health care professional for interpretation of pressure measurements.

Displaying Stored Results

1. After the measuring, you can review the measurements in the current memory bank by pressing the button “MEM”. Now the LCD displays the amount of the results in the current bank. See Fig. 7-1.
2. You can also press the “MEM” button in Clock Mode to display the stored results. The current memory bank will flash and the amount of results in this bank will be displayed. See Fig. 7-2 Press the “START” button to change to the other bank. See Fig. 7-3. Confirm your selection by pressing the “MEM” button. The current bank will also be confirmed automatically after 5 seconds with no operation
3. After selecting the memory bank, the LCD will display the average value of the last three results in this bank. See Fig. 7-4 & 7-5. If no results are stored, the LCD will show dashes as shown in Fig. 7-6.
4. When the average is displayed and you press the “MEM” button, the most recent result will be displayed. See Fig. 7-7. Then the blood pressure and the pulse rate will be shown individually. Possibly the irregular heartbeat symbol may flash. See Fig. 7-8 & 7-9. Press the “MEM” button again to display the next result. See Fig. 7-10. In this way, repeatedly pressing the “MEM” button displays the respective results measured previously
5. When displaying the stored results, the monitor will turn off automatically after 1 minute of no operation. You can also press the “START” button to turn off the monitor manually

Deleting Measurements from the Memory
When any result (except average reading of the last three results) is displayed and you keeping pressing the “MEM” button for three seconds, all results in the current memorybank will be deleted after three “beeps”. The LCD will show Fig. 8; pressing the “MEM” or the “START” button will turn off the monitor.

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.) also must be taken into consideration. Consult with your physician for accurate assessment, and never change your treatment by yourself

Definition and classification of the blood pressure values according to WHO / ISH

Technical Alarm Description

The appliance will show “HI” or “Lo” as a technical alarm on LCD with no delay if the determined blood pressure (systolic or diastolic) is outside the rated range specified in part “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 inactivated. This alarm condition is assigned as low priority according to IEC 60601-1-8. The technical alarm is non-latching and need no reset. The signal displayed on LCD will disappear automatically after about 8 seconds

Troubleshooting

LCD Display shows abnormal result

| The cuff position was not correct or it was not properly tightened.| Apply the cuff correctly and try

again.

Body posture was not

correct during testing.

| Review the section “Body posture during measurement” of the instructions and try again.
Speaking, arm or body movement, angry, excited or nervous during testing.| Re- test when calm and without speaking or moving during the test.
Irregular heartbeat (arrhythmia)| It is inappropriate for people with serious arrhythmia to use this elec- tronic sphygmomanometer.
Problem| Possible cause| Solution
---|---|---
LCD shows the symbol for a low battery| Low battery| Change the batteries
LCD shows “Er 0”| Pressure system is unsta- ble before measurement.| ****

Don’t move and try

again.

LCD shows “Er 1”| Fail to detect systolic

pressure.

LCD shows “Er 2”| Fail to detect diastolic

pressure.

LCD shows “Er 3”

| Pneumatic system blocked or cuff is too tight during inflation.| Apply the cuff cor- rectly and try again. If the monitor is still abnormal, please contact the local dis- tributor or the factory.

LCD shows “Er 4”

| Pneumatic system leakage or cuff is too loose during inflation.
Problem| Possible cause| Solution
---|---|---
LCD shows “Er 5”| Cuff pressure above

300 mm Hg

|

Measure again after five minutes. If the monitor is still abnor- mal, please contact the local distributor or the factory.

LCD shows “Er 6”

| More than 3 minutes with cuff pressure above 15 mmHg
LCD shows “Er 7”| EEPROM accessing error
LCD shows “Er 8”| Appliance parameter

checking error

LCD shows “Er A”| Pressure sensor parameter error
No response when you press a button or load batteries.| Incorrect operation or strong electromagnetic interference.| Take out batteries for five minutes, and then reinstall all batteries.

Maintenance

1. Do not drop this monitor nor subject it to strong impacts.

2. Avoid high temperatures and direct sunlight. Do not immerse the monitor in water as this will result in damage to the monitor.

3. If this monitor was stored at a temperature near the freezing point, allow it to come to room temperature before use.

4. The 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. The 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.

5. Do not attempt to disassemble this monitor.

6. Not servicing / maintenance while the monitor is in use.

7. If you do not use the monitor for a long time, please remove the batteries.

8. It is recommended the performance should be checked every 2 years or after repair. Please contact the service centre.

9. Clean the monitor with a dry, soft cloth or a soft cloth squeezed well after moistened with water, diluted disinfectant alcohol, or diluted soapsuds.

10. No component in the monitor can be serviced by the user. The circuit diagrams, component part lists, descriptions, calibration instructions, or other information which will assist the user’s appropriately qualified technical personnel to repair
    those parts of equipment which are designated repairable can be supplied.

11. 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.

12. It is recommended that the cuff should be disinfected 2 times every week if needed (for example, in a hospital or in a clinic). Wipe the inner side (the sidethat contacts skin) of the cuff with a soft cloth moistened with ethyl alcohol (75 – 90 %) and squeezed, then dry the cuff by airing.

Electromagnetic Compatibility Information

Table 1 – Emission

Group 1, Class B

| Home healthcare environment
Harmonic distortion| IEC 61000-3-2

Class A

| Home healthcare environment
Voltage fluctuations and flicker| IEC 61000-3-3

Compliance

| Home healthcare environment

Table 2 – Enclosure Port

Home Healthcare Environment
Electrostatic Discharge| IEC 61000-4-2| ± 8 kV contact

± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air

Home Healthcare Environment

Radiated RF / EM field

|

IEC 61000-4-3

| 10 V/m

80 MHz – 2.7 GHz

80 % AM at 1 kHz

Proximity fields from RF wireless communications equipment|

IEC 61000-4-3

|

Refer to table 3

Rated power frequency magnetic fields| IEC 61000-4-8| 30 A/m

50 Hz or 60 Hz

Table 3 – Proximity Fields from RF Wireless Communications Equipment

Professional healthcare facility environment
385| 380 – 390| Pulse modulation 18 Hz, 27 V/m
450| 430 – 470| FM, ± 5 kHz deviation, 1 kHz sine, 28 V/m
710| ****

704 – 787

| ****

Pulse modulation 217 Hz, 9 V/m

745
780
810| ****

800 – 960

| ****

Pulse modulation 217 Hz, 28 V/m

870
930
1720| ****

1700 – 1990

| ****

Pulse modulation 217 Hz, 28 V/m

1845
1970
2450| 2400 – 2570| Pulse modulation 217 Hz, 28 V/m
5240| ****

5100 – 5800

| ****

Pulse modulation 217 Hz, 9 V/m

5500
5785

References

• Proficare Germany Startseite

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